Would you like the Opportunity…

...to Make a Difference

Transonic® offers employees the chance to make a difference. As a pioneering, high tech company, employees bring flow measurement benefits to: operating rooms where intraoperative flow measurements inform surgeons; research laboratories worldwide, setting the stage for medical advances; dialysis clinics where measurements enable proactive treatment to extend the lives of patients with kidney failure. In short, Transonic flow measurement technologies save lives.

... for Growth

Motivated employees enjoy an opportunity for both personal growth and professional advancement in a flexible, friendly, open, working environment. The company offers an excellent benefit package, including fully paid medical insurance, along with recognition for individual initiative and accomplishment.

... for Quality of Life

Transonic’s headquarters is located in cosmopolitan Ithaca, NY, home to Cornell University and Ithaca College. Located in the unsurpassed beauty of the New York Finger Lakes region; in Ithaca, rural life and recreation interface with city sophistication and world class culture.
Click here to view our Prospective Employee Brochure

Current Opportunities

Please submit your resume and cover letter via email using the "Apply here" link associated with the position or by mailing them to:
Attn: Human Resources
Transonic Systems Inc.
34 Dutch Mill Rd.
Ithaca, NY 14850

 

 

Director of Engineering
Engineering

Ithaca, NY

This position is responsible for the planning, management and coordination of all projects and activities of the Engineering Department. Responsibilities include the maintenance of legacy products as well as new product development and the management of all stages of design and development and pre-production engineering phases while maintaining Company standards in delivering high quality products.

Duties and Responsibilities:

  • Plan, direct and manage the coordination and overall integration of technical activities for engineering projects including legacy products and new product engineering
  • Assess project feasibility by analyzing and evaluating available technology, resource needs, and market demand while keeping in mind regulatory and quality parameters, and Company goals
  • Ensure all engineering projects, initiatives, and processes are in conformance with organization’s established policies and objectives
  • Manage project schedules and assure that product development stays on schedule
  • Oversee annual employee performance reviews for the Engineering staff including recommendations for salary adjustments
  • Take the lead role in employee management, including talent management and assessment of experience and knowledge requirements within the department
  • Direct recruitment and make recommendations for the addition of or elimination of positions in the Engineering Dept
  • Monitor Departmental Expenses to Budget and propose new annual departmental budgets annually during May and June
  • Direct, review, and approve project design changes.
  • Confer with management, production, and/or marketing staff to discuss project specifications or procedures
  • Perform administrative functions, such as reviewing or writing reports, reviewing and approving of expenditures including materials and services, enforcing rules, standards and policies within the department
  • Monitor all time and material expensed by the Engineering Dept to control project cost and project completion.
  • Establish technical and project goals within outlines provided by top management and within the Company standards
  • Supervise staff to assure that Design engineering documents, product development meeting minutes and product development test reports are consolidated into Design History File (DHF) including overseeing the ECN process and change validation documentation process are updated as needed
  • Assure that design control and risk analysis requirements are met through the design process
  • Review individual monthly engineering status reports and assure they are compiled into overall Engineering Department Projects Report
  • Work in coordination with Manufacturing and Manufacturing Engineering for product transfer to pre-production, production and/or product release including assurance of proper and complete documentation, training and instruction as required
  • Perform other work-related duties as requested, directed or assigned by management.

Education and Experience

  • BS in Engineering is required
  • Background in science, technology, engineering, and mathematics (STEM) educational disciplines is required
  • Experience in the medical device industry is preferred.

Knowledge, Skills and Abilities

  • Proficient in the practical application of engineering science and technology. This includes applying principles, techniques, procedures, and equipment to the design and production of various goods and services.
  • Knowledge of design techniques, tools, and principles involved in production of precision technical plans, blueprints, drawings, and models
  • Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.
  • Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming
  • Ability to manage, motivate and direct employees including ability to identify and assess staff strengths and weaknesses
  • Capable of assessing, managing and forecasting the financial expenditures of the department in keeping with overall Company budget requirements
  • Understanding of appropriate use of equipment, facilities and materials needed to successfully manage department projects
  • Communicate effectively, in writing and verbally, with direct reports, other department managers and upper management
  • Understanding of the implications of new information for both current and future problem-solving and decision-making

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Director of Regulatory Affairs
Regulatory

Ithaca, NY

The Director of Regulatory Affairs is ultimately responsible for Transonic’s planning, compliance, and documentation in accordance with the U.S. Code of Federal Regulations (e.g., 21 CFR Part 820), Canadian Medical Device Regulations (SOR/98-282), EU Medical Device Directive (93/42/EEC), soon to be MDR, Japan’s Pharmaceutical and Medical Device Act, and other applicable country regulations. You are charged to ensure that Transonic clinical products available for commercial distribution meet all applicable specifications and are appropriately registered for domestic and international sale will pass audits by various notified bodies.

Duties and Responsibilities:

  • Lead the preparation of U.S. FDA 510(k) submissions including strategic approaches, presub meetings, and managing other departments to provide the proper materials; so as to assure that all our product registration are accurate, complete, and products are registered in a timely manner.
  • Provide guidance on and review the regulatory aspects of technical files for CE marked products; so at to assure that they are accurate, complete, and products are approved in a timely manner.
  • Maintain a product registration documentation filing system that is accurate, complete, and pertinent to product registration in other countries of sales, and support sales divisions and distributors to register those products in a timely manner.
  • Provide timely notification of document changes (e.g., ISO 13485 Certificate) to the appropriate health authorities.
  • Review and provide guidelines to assure that all product labeling complies with applicable regulatory requirements both domestic and international.
  • Review and provide guidelines to assure that company website and marketing collateral accurately reflects product descriptions, intended use, and specifications.
  • Provide leadership and assistance during external audits with regulatory agencies and customers to ensure findings/observations are properly documented and corrective actions are efficiently and effectively taken.
  • Notify appropriate health authorities of any medical device adverse events.
  • Supervise any product recalls and ensure the appropriate health authorities are notified in a timely manner and periodic update reports are submitted until the product recall is closed by those authorities.
  • Participate as the regulatory representative on product development teams.
  • Participate on Risk Management and Risk Analysis reviews for all products.
  • Perform duties as the regulatory management representative for Transonic Systems Inc. in accordance with domestic and international regulations.
  • Support regulatory requirements and compliance for all divisions of Transonic Systems Inc.
  • Lead the Transonic team in development of yearly Clinical Evaluation Reports
  • Review existing legacy medical device files against current state of affairs of legacy medical technical files to identify any gaps in compliance with procedures and requirements of Medical Device Directive MDD 93/42/EEC (amended by 2007/47/EC), soon to be amended by MDR.
  • Perform other work-related duties as requested, directed or assigned by management.

Education and Experience

  • Requires a BA degree in science, medical or a related field
  • At least 5 years relevant experience within the regulatory affairs discipline
  • Knowledge of EU Medical Device regulatory requirements, both MDD & MDR
  • Experienced in the medical device field.
  • Experience with volume and non-volume submission of U.S. FDA 510(k).
  • Experience with creating and submitting EU Technical Files for CE marking.
  • Experience with submission of Class II, III, and IV product applications for Health Canada.
  • Experience with submission of Class II, III, and IV product dossiers for Japan.
  • Experience and/or knowledge of other international product registration processes.
  • Experience in Statistical Process Controls (SPC)
  • Experience and/or knowledge of FDA Good Manufacturing Practices
  • Experience and/or knowledge of ISO 13485 Medical Device Quality System
  • Regulatory Affairs Certification (RAC) by the Regulatory Affairs Professional Society (RAPS) preferred.
  • Experience in evaluating and drafting CER’s preferred

Knowledge, Skills and Abilities

  • Ability to work independently & self-direct.
  • Excellent organizational skills.
  • Excellent written, oral, interpersonal, group and telephone communication skills.
  • Ability to use Microsoft Office Suite including Microsoft Access, Word, Excel, PowerPoint, and Outlook.

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Clinical Application Specialists
Regulatory

Ithaca, NY

The Clinical Application Specialist is the internal company expert on all aspects of Transonic Clinical Products with an initial high focus on our Perfusion, ECMO and CABG product lines. The Clinical Application Specialist handles all internal & external aspects of the product lifecycle from development to release to product maintenance. The Clinical Application Specialist ensures that all sales representatives, distributors, internal staff (as needed) and customers are adequately trained in product and application specifics either by direct training, training at evaluations, web training or through the development of training materials that are disseminated by Sales staff. Training materials include online training, training platform management, assistance with and creation/dissemination of technical notes, sales notes, manuals, quick reference guides, power points and more. This position helps coordinate and manage product activities such as new product design through the feedback of user needs to the engineering team. They also work with the Surgical and Vascular Access Marketing Managers to develop strategic product and marketing plans to champion Transonic devices, to launch products at tradeshows and help develop launch materials (tradeshow backwalls, videos, etc.) and they work in tandem with other staff to resolve issues that improve marketplace acceptance. They also work with key opinion leaders to expand use of the devices through reference programs or studies.

Duties and Responsibilities:

  • Identify the educational & training needs of sales force (international & US) and customers and develop educational material or training programs or classes on products.
  • Teaching or instructing others (internal staff, external staff, users) including hosting educational presentations at tradeshows
  • Work with Customers and Key Opinion Leaders on new application development
  • Advise others on applications for product line
  • Work with Engineering & R&D to bring market feedback and voice of customer to existing product updates and new product development.
  • Conduct opinion surveys or needs assessments.
  • Track market trends and alert execs and staff of significant changes impacting Transonic
  • Keep the pulse of the existing market and advise executives on changes, competitive updates, and new developments that affect the surgical product line.
  • Provide guidance and expert advice to management or other groups on technical, systems- related or process-related topics.
  • Write Manuals, Quick Reference Guides, Inservice checklists and other product related materials
  • Develop training videos in conjunction with other marketing staff to advance product knowledge
  • Perform other work-related duties as requested, directed or assigned by management

In conjunction with Surgical Marketing Manager:

  • Identify, develop, or evaluate marketing strategy, based on knowledge of Transonic’s objectives, market characteristics, and cost and markup factors.
  • Formulate, direct, or coordinate marketing activities to promote products or services
  • Participate in, and/or assist in coordination of special events or programs or tradeshows
  • promoting the surgical product line
  • Develop marketing plans or strategies.

Education and Experience

  • Experience as a Perfusionist and/or experience in sales and/or marketing of perfusion related products for surgical or critical care applications.
  • M.B.A. would be beneficial.

Knowledge, Skills and Abilities

  • Specific experience in cardiothoracic, perivascular, minimally invasive, and robotic surgery markets a distinct advantage.
  • Able to communicate with and present to medical professionals
  • Project management skills a plus
  • Manage multiple priorities with minimum supervision.
  • Superior communication skills – both written and verbal - including demonstrated presentation skills.
  • High computer skills
  • Proven leadership and effective decision-making capabilities.
  • Self-motivated and highly organized

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Apply here


Scientific/Medical Writer
Marketing

Ithaca, NY

Transonic is looking for a key marketing team member to lead the marketing communication efforts across all of our product lines and applications. As a dynamic, critical-thinking, detail-oriented, self- directed initiator you will spot opportunities to develop and optimize our literature and marketing communications, thrive in a fast-paced environment and be able to think along with multiple projects and priorities.

We are seeking a Scientific/Medical Writer to work within the Marketing Department to develop, write, edit, and produce a variety of written materials for a variety of audiences via multiple modes of dissemination (social media, email, the web, PowerPoint, and printed media). Audiences will include the general public, sales representatives and distributors, researchers, clinicians, and surgeons. This is a key position in the marketing department as the Scientific/Medical Writer works across all the product lines and with all of the marketing staff as the foundational document originator for all Transonic related marketing, training, and resource material.

Duties and Responsibilities:

  • In collaboration with Marketing and Product Managers, generate blogs, press releases, technical, application and medical notes, video scripts, publication briefs, white papers, booklets, product, and sales flyers/consumables for a spectrum of research and medical disciplines.
  • Assist in writing Manuals, Quick Reference Guides, Inservice checklists and other product related materials.
  • Assist in the development, review, and evaluation of all Communications from or to Transonic, including:
    • study-related documents for training users ofT ransonic products,
    • formatting journal articles,
    • application protocols by collaborating with Product Managers, and Product Users
  • Keep up to date with Quality and Regulatory updates and requirements as they relate to Transonic products and messaging in conjunction with the QA/RA departments.
  • Assist in maintaining the Transonic website pages for medical relevancy and accuracy.
  • Responsible for writing and disseminating a monthly Marketing Dispatch to Transonic’s internal
  • family of sales reps and distributors, apprising them of recent marketing activities.
  • Locate articles and scientific publications that cite use of Transonic and competitive products, create summary reviews of the key points of these articles for dissemination as needed and maintain a database of the publications found/purchased for internal reference.
  • Respond to other needs that may arise within the department and/or Company that may surface and perform as requested, directed, or assigned by management.

Education and Experience

  • Bachelor’s degree or higher in biological sciences or biomedical engineering would be preferred but we are open to related fields as well; if you feel this job description would be a good fit for you, reach out and let us know why and how you feel your background would suit.
  • Desktop Publishing: Comfortable with Adobe Suite of software (InDesign, Photoshop, Acrobat) as well as Microsoft Word & PowerPoint
  • Professional writing work experience is preferred.

Knowledge, Skills and Abilities

  • Superior communication skills (both written and verbal) including demonstrated presentation skills are paramount.
  • Ability to organize complex medical and scientific information and present it clearly, concisely and in an engaging, easy to read manner.
  • Responsive, organized, able to multi-task, and prioritize work with minimal supervision.
  • Able to receive constructive criticism and not be ruffled by rounds of editing.
  • Self-initiator, creative, and able to work with others.
  • Social media savvy – active platforms are (currently) LinkedIn, FaceBook and Twitter.

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Apply here


Human Resources Coordinator
G&A / Finance

Ithaca, NY

The purpose of this position is to maintain the payroll, benefits, and human resource records for the Transonic family of Companies. This includes, but is not limited to, payroll processing, benefits administration, HR recordkeeping and financial/payroll reports. This role also provides support for recruitment, review, and implementation on ongoing support of company policies and procedures as they relate to employees.

Duties and Responsibilities:

  • Prepare or maintain employment records related to events, such as hiring, termination, leaves, transfers, or promotions, using human resources management system software.
  • Address employee relations issues which includes concerns and suggestions.
  • Confer with management to assist in development and implementation of personnel policies and procedures.
  • Interpret and explain human resources policies, procedures, laws, standards, or regulations to management and the employees.

Payroll & Benefit Administration

  • Maintain employment, payroll, and benefit enrollment data in HRIS - ADP’s Workforce Now
  • Maintain and update human resources documents, such as employee handbooks, directories, performance evaluation forms, and various other HR-related forms
  • Planadministratorfor401kretirementplan,includingprocessing/conductingannual NDT testing, plan review, employee educational workshops, filing 5500 and audit support
  • Administeremployeebenefitplans(Medical,Dental,Visionandotherancillaryplans)
  • OpenEnrollment–coordinateandfacilitateOpenEnrollmentmeetingsforonsiteand offsite/remote employees
  • Maintain current knowledge of all benefit plans and assist employees with any issues or questions that arise
  • Communicate with broker agency, TPA’s and all benefit vendors including reviewing invoices, reviewing/updating/amending plan documents
  • Prepare periodic payroll & benefit reports such asemployee census and wage & time reports

Recruitment activities

  • Coordinate all personnel recruitment activities
  • Create, review and update job descriptions for posting using several websites and with local employment agencies and recruiters
  • Perform searches for qualified job candidates, using sources such as resume databases, networking, Internet recruiting resources/postings, job fairs, recruiting agencies, or employee referrals.
  • Review employment applications and resumes to match applicants with job requirements.
  • Select qualified job applicants and refer them to managers ,assist in the interview and selection process.
  • Interview job applicants to obtain information on work history, training, education, or job skills.
  • Coordinate with outside staffing agencies to secure temporary employees, based on departmental needs.

Employee Engagement / New Hires / Terminations

  • Clarify Company policies or procedures as needed or required to employees
  • Maintain updated knowledge of payroll & benefit laws and regulations for multiple states, primarily New York
  • Coordinate and facilitate employee required annual trainings, periodic skills based training (both internal and external training) including keeping records of all training and tracking expiration of required certifications
  • Support Sales and Marketing staff in maintaining required certification including periodic background checks as deemed necessary per policy or as required by customers or vendors
  • Maintain all employee training records including Work Instruction training records
  • Perform other work-related duties as requested, directed, or assigned by management
  • Clarify Company policies or procedures as needed or required to employees
  • Maintain updated knowledge of payroll & benefit laws and regulations for multiple states, primarily New York
  • Coordinate and facilitate employee required annual trainings, periodic skills based training (both internal and external training) including keeping records of all training and tracking expiration of required certifications
  • Support Sales and Marketing staff in maintaining required certification including periodic background checks as deemed necessary per policy or as required by customers or vendors
  • Maintain all employee training records including Work Instruction training records
  • Perform other work-related duties as requested, directed, or assigned by management

Education and Experience

  • Associates degree in relevant major preferred
  • 5+ years’ recent experience in Payroll and Human Resources required

Knowledge, Skills and Abilities

  • Must be trusted to keep high degree of confidentiality regarding all HR matters, HR records including payroll, benefit selections, and confidential Company data
  • Must have excellent communication skills both written and oral
  • Excellent interpersonal skills with the ability to maintain composure while working with many different personality types, even in difficult situations
  • Position requires being reliable, responsible, and dependable
  • Adaptability/Flexibility — must be open to change and to considerable variety in the workplace
  • Strong time management skills with the ability to adhere to deadlines and perform time critical tasks efficiently and accurately
  • High Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook
  • Familiarity with accounting software
  • Must have good understanding of an integrated Payroll & HR System, preferably ADP Workforce Now
  • Ability to maintain a high level of accuracy with high attention to detail in a fast-paced environment
  • Occasional overtime will be required

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Mechanical Design Lead
Engineering

Ithaca, NY

This position is responsible for performing engineering duties as well as overseeing the planning and designing of products, new product prototypes, accessories and other mechanically functioning equipment.

Duties and Responsibilities:

  • Make design modifications as needed to support resolution of manufacturing floor product issues
  • Design products using SolidWorks and consults with other discipline engineering and manufacturing teammates to ensure the designs are feasible
  • Develop and build prototypes and run tests to measure their level of functions
  • Record and evaluate test data, altering designs as necessary to bring them to safety, performance and efficiency standards
  • Calculate cost estimates for final product designs, and release reports to supervisors, incorporating cost of labor, material, delivery and overhead
  • Attend weekly team meetings to provide progress reports, report task progress, completion and issue resolution using Microsoft Project software
  • Be an available resource to R&D to discuss upcoming generation of TSI products and support their need for design and building of early prototypes
  • Write RFQ technical specifications, interface with and advise on vendor progress and perform first article inspection of new products/parts.
  • Produce standard designs using SolidWorks software and create assembly prints, mechanical drawings and fabrication specifications
  • Create, develop and test products
  • Solve problems by applying the principles of physics, chemistry and mechanics to the design problem
  • Prepare calculations on the proposed design before completing technical drawings
  • Institute quality control procedures to resolve drawing/design related quality issues
  • Establish drawing standards for the company
  • Oversee the conversion of older CAD based drawings into SolidWorks
  • Perform other work-related duties as requested, directed or assigned by management.

Education and Experience

  • Bachelor’s degree in mechanical engineering
  • Minimum of 10 years of experience in an engineering role
  • Strong computer skills with proficiency in SolidWorks and FEA
  • PE license preferred
  • Experience in designing medical devices is strongly preferred

Knowledge, Skills and Abilities

  • Demonstrated competency in remaining current on published design standards as it relates to the various design basis for medical devices, i.e. Injection molding, machining, mechanical fixturing, etc.
  • Demonstrated competency is precise engineering design discipline, do it right the first time
  • Demonstrated competency in drawing design layout, tolerances, drawing notes
  • Demonstrated competency in tolerance stack up tools
  • Demonstrated competency in FDA medical device stage gate procedures and mandatory documentation
  • Demonstrated competency is adapting multiple versions of same product, must be persistent, strong problem-solving skills, and highly disciplined
  • Creativity to generate innovative ideas
  • Works fast and accurate
  • Must be thorough
  • Strong math skills are mandatory
  • All workmanship should be world class quality
  • Willing to continuously be educated through company-paid training courses
  • Can convert end user needs into design requirements
  • Knows when to ask for help
  • Can prepare accurate time estimates to perform tasks
  • Exceptional written and verbal communication skills
  • Self-motivated

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Software/Test Engineer - LabVIEW
Manufacturing Engineering (MFG O/H)

Ithaca, NY

Maintains the manufacturing software life cycle program. Exercises developmental and analytical skills in the resolution of production issues through remote monitoring and test software. Demonstrates creativity in implementing process improvements and new manufacturing methods including the conception, design and implementation of new software and tools. Utilizes project management skills to transition new or improved software into Production, including fast-tracking of incubator products. Analyze and summarize risks, costs, and benefits regarding alternative courses of actions. Prepares technical reports and makes recommendations. Supervises fellow software development team members and ensures compliance to software SOP’s. Prepares and executes process validations.

Duties and Responsibilities:

  • Design, develop and maintain software for the control and data acquisition of internal test benches using LabVIEW.
  • Plan, track, and implement all phases of the software life cycle, from inception and planning through development, validation, transfer and maintenance.
  • Performs project engineering work from design to implementation in accordance with the company's policies.
  • Investigates software bugs and develops plans for solutions in line with economic, personnel and environmental considerations.
  • Draft and execute validation and verification protocols for software processes, new and sustaining.
  • Interface with various I/O and peripherals through a variety of interfaces and protocols: Ethernet, RS-485/232, ModBUS, etc.
  • Clear understanding of Queued State Machine - Producer Consumer architecture to communicate to multiple sub processes.
  • Design and develop software for real time devices utilizing National Instruments Real-Time and FPGA toolkits for LabVIEW Support, modify and upgrade existing software and test benches.
  • Maintain legacy manufacturing software suites currently deployed to the production floor Develop and implement continuous process improvement projects that decrease programming errors, reduce cycle time and/or reduce costs.
  • Maintain Work Instructions, BOM’s, and Routers affected by software projects using the Document Control System.
  • Gathers technical specifications and designs from key team members and customers to determine and create test system controls and system requirements and functional specifications to conceptualize, design, develop and implement new software and tools.
  • Participate in PFMEA activities when applicable.
  • Utilize SPC where applicable to monitor critical device performance parameters and establish meaningful software process control limits.
  • Apply DOE and statistical tools to identify root cause(s) software malfunction and propose and implement corrective actions.
  • Identify and resolve manufacturing errors expeditiously with attention to impact on safety/ergonomics, quality, cost and production schedules from software.
  • Support improvement projects by developing cost justifications and savings analysis.
  • Performs training as assigned.
  • Perform other work-related duties as requested, directed or assigned by management.

Education and Experience

  • BS in Computer Science, Engineering, or Software Engineering required. [or CLD/CLA Certification]
  • Proficiency in LabVIEW required, National Instruments Certified LabVIEW Developer (CLD) preferred.
  • At least 5 years of LabVIEW development experience.
  • Experience in medical device industry or ISO 13485 compliant facility preferred.
  • Must understand GMP with regards to software design, documentation, qualification and implementation.
  • Experience in test systems design preferred.

Knowledge, Skills and Abilities

  • Excellent analytical and problem-solving skills with the capability of explaining the underlying concepts and principles.
  • Proficient in LabVIEW development.
  • Solid understanding of test systems and software integration techniques.
  • Working knowledge of electronics and systems design required.
  • Prior success in the development and implementation of process improvement initiatives.
  • Working knowledge of VisualBasic is a plus.
  • Requires understanding of validation concepts and document control.
  • Excellent written and verbal communication skills including effective presentation of technical data to all levels within the organization.

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Apply here


‘Transonic Inside’ Applications Enginee
Engineering

Ithaca, NY

The ‘Transonic Inside’ (TI) Applications Engineer position is an essential part of Transonic’s OEM business and supports a diverse group of innovative clients in the medical device space that wish to add or already have Transonic capabilities inside their devices. The position is integral to client relations for a large section of our business and good communication and project management skills are critical. The position is a vibrant and constantly flexing one with broad opportunities for engagement; there is huge growth potential in this position. This position will oversee and manage the TI co-engineering and customer relations throughout the entire TYI product lifecycle, including and not limited to:

  • Provide product information and support to potential new clients via email, skype and on-site client meetings to convert new leads to a TI co-engineering project
  • Application support with the customer when a TI demo product is delivered for evaluation, with scoping of the customer’s TI needs, and demo unit application troubleshooting as needed, and co-developing with the customer their user requirements document
  • In conjunction with Transonic Engineering and R&D, develop Project Plans, time estimates & quotes for new clients
  • Represent the client’s needs when Transonic executes the TI design, verification, and validation for new and existing TI client projects
  • Support established OEM clients with their customer service needs, delivery dates, on-site audits, etc.
  • Travel to tradeshows occasionally


The position receives direction from the executive team, works closely with Engineering and R&D for product development, with Customer Service and Manufacturing for TI product deliveries, with Quality and Manufacturing Engineering on complaint handling, and works closely with the OEM Marketing Lead on account retention strategies and market development.

 

Duties and Responsibilities:

Existing Customer Support:

  • Support existing OEM customers through calls, visits at their company and onsite at Transonic and supply customers with information on their projects and products.
  • Work with existing customers to gather expectations, forecasts, ship dates, etc. and follow up with various stakeholders to ensure that the customer’s needs are understood throughout the company and that their needs are being met.
  • Work with Engineering Department, Manufacturing Engineering and Manufacturing to implement and manage changes to existing products.
  • Spark current customers to expand their existing products with innovative new parameters and possibilities
  • Help marketing with account retention strategies

Market Development:

  • Participate in key sales situations for the products/projects – travel to customer sites or host customers onsite at Transonic, develop meeting plans and agendas, gather customer’s initial user needs
  • Develop highly customized sales quotes and contracts.
  • As needed, set up prototype board/sensor/tubing benches and mockups at Transonic, to do quick concept tests and de-risking tests to determine project feasibility, and/or support customers at their site to perform feasibility testing and TI specifications development
  • Build project plans and GANNT charts through Celoxis and use other development and scheduling tools
  • Work with Quality, Engineering and Manufacturing to troubleshoot application-specific inquiries
  • Interface extensively with marketing/sales, technical support, inventory control, manufacturing and R&D to assure customer needs are met and that product performance is within Transonic’s gold standard
  • Perform other work-related duties as requested, directed, or assigned by management

Education and Experience

  • Bachelors’ degree in Biomedical Engineering, Software or Electrical Engineering
  • Good knowledge of process or automation engineering, GMP or GAMP is a plus
  • Strong project management experience

Knowledge, Skills and Abilities

  • Must have outstanding written and verbal communication skills including presentation and training competency
  • Must have demonstrated skills in the MS Office Suite (Word, Excel, Outlook and PowerPoint)
  • Excellent interpersonal skills and ability to be a team player
  • Ability to establish and maintain excellent rapport and credibility with potential customers, existing customers and other industry contacts
  • Ability to be creative and innovative to assist in growing our OEM business
  • Must be dynamic, upbeat and flexible with the ability to work in a fast-paced, diverse team environment

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Project Manager
Engineering

Ithaca, NY

The Project Manager is responsible for leading cross-functional teams in the New Product Development (NPD) and Sustaining Engineering efforts to bring new and innovative flow measurement system products from concept to commercialization. This role will apply Project Management best practice knowledge, tools, methodologies and techniques to meet or surpass the needs and expectations of all stakeholders.

Duties and Responsibilities:

  • Analyze, plan, and develop requirements and standards about scheduled projects
  • Understand the revenue impact of project management decisions taken.
  • Train all assigned project personnel to understand the revenue impact of their actions.
  • Be able to effectively manage concurrently up to three major projects (each with a $1-2M USD budget, multiple departmental resources, and multiyear time horizon)
  • Create and manage the personnel and capital budget of assigned projects
  • Responsible for managing the task level definition, dependencies of tasks and the associated schedule of all tasks and required resources.
  • Assign and oversee the daily tasks of technical personnel while ensuring all subordinates are actively working toward established milestones
  • Hold regular technical team meetings to determine progress and address any questions or challenges regarding projects
  • Communicate effectively at the company executive level and at the individual contributor level
  • Design and distribute in a timely manner formal reporting on assigned project budgets, manpower utilization including shortages, skill set analysis and scheduling issues and resolutions
  • Create timely and professional reports as required by the company clients who may be funded the assigned projects
  • Determine and define clear deliverables, roles and responsibilities for staff members required for specific projects or initiatives
  • Effectively negotiate with multiple cross company resources for timing and scheduling of resources, facilities, infrastructure, and other assets.
  • Research and evaluate hardware and software technology options and weigh the cost/benefit analysis when making large purchase recommendations on behalf of the company
  • Project skill sets and manpower to complete contractual project scopes and timeline. Recruit and train exceptional employees to fulfill posted positions within the technical department
  • Work effectively within the current set of project management tools deployed within the company.
  • Perform other work-related duties as requested, directed or assigned by management

Education and Experience

  • Master's degree in Project Management or related technical field required, with strong working-level electronic and mechanical engineering experience preferred
  • Work experience must include successful completion of a minimum of $5M annually in project management successes
  • Minimum of 10 years project management experience in the industrial electronics, metrology, or medical device market
  • Must have experience in demonstrating performance whereby a portion of any annual compensation was tied to meeting stretch auditable performance metrics
  • Project experience must include complex projects that involve iterative design of hardware and software
  • Must have demonstrated experience in use GIT Lab
  • Must be a certified user of Microsoft Project
  • Professional Project Management Certification from accredited intuition preferred. Preferred project managements certification includes PMP (Project Management Professional), CAPM (Certified Associate in Project Management), or CSM (Certified Scrum Master)
  • Experience mentoring, coaching, and developing rising talent in the technology department
  • Experience working in a high-level collaborative environment and promoting a teamwork mentality
  • Managerial experience applying analytical thinking and problem-solving skills

Knowledge, Skills and Abilities

  • Working knowledge of FDA product development procedures and documentation requirements is preferred
  • Must have managed a combination of inside company project resources along with outside third-party consultants
  • Must have a working knowledge of using available executive dashboard and data visualization development tools such as Excel, Tableau, Power BI etc.
  • Must be able to demonstrate conflict resolution skills
  • Must have proven critical thinking skills
  • Must be able to project resolution to issues before they negatively impact company revenue
  • Demonstrated understanding of Project Management processes, strategies, and methods
  • Excellent time management and organizational skills and experience establishing guidelines in these areas for others
  • Strong sense of personal accountability regarding decision-making and supervising department teams
  • Ability to predict challenges and seek to proactively head-off obstacles

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Quality Engineer
Quality Assurance

Ithaca, NY

This is a role in Quality Assurance focusing on New Product Development, pre-market access, production controls and post-market surveillance. Additional duties and projects to be assigned based on business needs and strengths and interests of the candidate.

Duties and Responsibilities:

  • Responsible for design and development quality including adherence to procedures for design input, review, output, V&V and transfer as well as initial production.
  • Monitor and ensure compliance with regulatory requirements (e.g. compliance with FDA, MDD/MDR, ISO13485:2016, etc.) and quality system requirements (Transonic Quality System). Advise, assist and lead the project team if any proposed course of actions could affect company or product compliance.
  • Participate in the Material Review Board (Non-conforming material investigation and disposition), Corrective Action Board (Failure Analysis and CAPA), and Audit process (Internal and External Audits).
  • Review and approve test and validation documents, receiving inspection requirements, sampling plans and Change Orders for product and process changes.
  • Initiate change orders to correct drawings, specifications, and Quality System Procedures.
  • Participate on Risk Management and Risk Analysis review for clinical and research products. Oversee and facilitate reportability decisions for incoming customer complaints.
  • Initiate and facilitate continuous improvement projects for Quality Systems as well as support continuous improvement efforts from other departments as needed. NOTE: Typical continuous improvement projects include supplier quality, process/procedure/workflow improvement, and product compliance planning.
  • Will be required to perform other work-related duties as requested, directed or assigned by management.

Education and Experience

  • A minimum of a BS in Engineering or related professional field is required
  • A minimum of 3 years in a “decision-making” position within Quality Assurance is required
  • Prior experience in a medical device or other highly regulated environment is preferred
  • Experience in Regulatory Affairs is a plus
  • Experience with electrical component inspection and assembly is a plus
  • ASQ Certification (CQE, CQA, CMDA, CSSBB) is a plus

Knowledge, Skills and Abilities

  • Good organizational skills
  • Good written, oral, interpersonal, group and telephone communication skills
  • Ability to use Microsoft Office Suite including Microsoft Word, Excel, PowerPoint and Outlook. Knowledge of Statistical Process Control preferred
  • Minitab experience is a plus
  • Proficiency in:
    • Design controls
    • Design validation and verification
    • Process validation (IQ, OQ, PQ)
    • Statistical sampling methods
    • Standards compliance such as electrical safety, EMC, biocompatibility, usability

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Sensor Development Engineer
Engineering

Ithaca, NY

As a Development Engineer in the Sensors Group, this position will play a critical role in the development of multi modal sensing, as well as sensor prototype testing and cost/performance optimization. The candidate will be heavily involved with developing and building prototype designs and testing cutting-edge prototype sensors.

Duties and Responsibilities:

  • Solve tough engineering problems, and work with other engineers to integrate cutting-edge functionality into novel prototypes
  • Design, develop, build prototypes, optimize, and tune signal-based algorithms to solve interesting problems sensor design
  • Maintain constant awareness of technologies, scientific developments, design software and hardware capabilities, as well as software tools to make the prototypes functional
  • Process and analyze R&D test data to integrate new knowledge of product development
  • Inventing and developing sensor materials, technologies, sensing systems to create new product opportunities for TSI.
  • Designing experiments, building apparatus, collecting and analyzing real world data to demonstrate fitness for use, robustness, and confirm efficacy in intended application.
  • Building and testing complex prototypes leading the low cost DFM-based product designs
  • Lead the company effort to build effective FMEA models of all sensors in PzFlex software
  • Utilize Design for Manufacturability guidelines to create products at the lowest possible cost of manufacturing while attaining desired product functionality.
  • Willingness to perform other duties as requested, directed or assigned by Management

Education and Experience

  • BS degree in biomedical engineering, electrical engineering, physics, or related discipline is preferred. A strong physics background is highly desired.
  • Strong mathematical skills are necessary
  • Specific knowledge of piezoelectric principle is highly desirable.
  • The candidate must be competent in a programming language such as, but not limited to, MATLAB, C++, Python, Mathematica, etc., and be capable of writing software routines to run experiments including data collection, storage, and basic data reduction.
  • 2+ years of experience preferred in developing and testing sensors and signal processing algorithms in real-world or comparable settings
  • Demonstrated experience in building sensor prototypes, testing them in a lab environment and successively adjusted the prototype design to meet DFM goals
  • Experience with test equipment, including data acquisition and processing, thermal chambers, network analyzers, etc.

Knowledge, Skills and Abilities

  • The candidate will be expected to spend large amounts of time in the lab as well as at the computer, performing hands-on prototype design & development tasks.
  • The candidate must be able to work with multidisciplinary teams and must possess excellent communication skills.
  • The individual must be highly self-motivated and must thrive in a multidisciplinary team environment.
  • Excellent written and oral communication skills are required
  • A working knowledge of designing prototype sensor designs in SolidWorks
  • Must be passionate about creating new devices and technologies, and ready to learn on the fly, solve complex problems, work closely with others, and creatively approach design and engineering tasks at all scales.
  • Strong electronic systems aptitude and problem-solving skills.
  • Strong data analytics skills including familiarity with principles of statistics
  • Ability to use logic when evaluating and synthesizing multiple sources of information.
  • Demonstrates understanding of interpreting analysis to include, but not limited to, its meaning, importance, and implications.
  • Demonstrates ability to defend analytic judgements with sound, logical conclusions and adapt analytic judgments when presented with new information, evolving conditions, or unexpected developments.
  • Demonstrates ability to produce timely, logical, and concise analytic reports, documents, assessments, studies, and briefing materials in formats including Microsoft Office tools (e.g., Excel, Word, PowerPoint, etc.), electronic/soft copy matrices and/or web-enabled formats.
  • Demonstrates ability to communicate complex issues clearly in a concise and organized manner both verbally and non-verbally, with strong grammar skills.
  • Demonstrates ability to develop structured research including, but not limited to, obtaining, evaluating, organizing, and maintaining information within security and data protocols.
  • Demonstrates ability to recognize nuances and resolve contradictions and inconsistencies in information.

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Junior Electronics and Software Design Engineer
G&A / EndoGear

Transonic EndoGear, Davis, CA

Transonic EndoGear Inc., a Davis, California based startup is seeking a Junior Electronics and Software Design Engineer for our new product development group. We specialize in the design and development of novel, totally implantable biotelemetry systems for academic research and pharmaceutical industries. The successful applicant will develop, design and test implantable and external electronic hardware and software components for such biotelemetry systems.

Duties and Responsibilities:

  • Design, implementation and testing of electronic subsystems for implantable and external electronic equipment and other hardware and software systems.
  • Electronic Hardware/Software Documentation

Desired Training and Experience

  • BS degree in Electrical/Electronic Engineering, or Biomedical Engineering
  • Two (2) or more years of professional experience in the following areas: Ultra- low power mixed analog and digital design experience, microcontrollers design experience, and embedded firmware development skills.
  • Proficiency with design engineering software tools for schematic capture and PC board layout software and experience working with PCB fabrication and assembly houses to take PCB designs from prototype to production.
  • Must have strong hands-on technical troubleshooting skills in both digital and analog circuits, and excellent soldering and SMD working skills using 0402, 0201 and 1005 size passive parts.
  • PC software development skills, especially Java, Visual Basic/C, or Labview applications development.
  • Design experience in microcontrollers, preferably using Microchip and or Atmel 8/16-bit series microntrollers.
  • Embedded firmware design and development using high level languages, preferably PICBasic Pro or C.

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Manufacturing Process Engineer
G&A / EndoGear

Transonic EndoGear, Davis, CA

Transonic EndoGear is a small innovative early-phase biomedical company (chronic implantable telemetry products) based in Davis, California. We are currently seeking a Manufacturing Process Engineer. The candidate for this position will require a broad spectrum of knowledge as he/she will wear many hats while being involved in different aspects of manufacturing and process development support and related administrative tasks. Responsibilities include guiding a small manufacturing and assembly team and creating/sustaining its workflow. The successful candidate will have a great opportunity to help develop and grow with the Company.

Duties and Responsibilities:

  • Organize, schedule, direct and control daily activities of manufacturing and process functions including all areas of production; final quality control testing and shipping deliverables.
  • Establish and implement improved standards for Manufacturing Process Instructions to increase product quality and minimize nonconformities.
  • Organize and plan work orders and daily manufacturing activities of production staff by communicating job expectations, planning, monitoring and appraising job results
  • Provide medical grade material selection and design guidance on mechanical aspects of implantable telemetry devices undergoing development and testing.
  • Mechanical CAD design and prototype fabrication both for manufacturing, testing and production.
  • Identify and lead testing efforts on material design improvements to existing products.
  • Initiate Purchase Orders and internal Work Orders to support planned production activities.
  • Write and update manufacturing work instructions; create testing protocols. Continuous improvement of production, to minimize non-value-added activities and reduce cost of quality. Document non-conformances and process changes into the Quality System.
  • Ensure the documentation and records are completed, reviewed and stored in accordance with GMP’s, internal work instructions, and quality requirements.
  • Assist in support and validation and verification activities for all new products and processes
  • Interface with Transonic Ithaca (TSI) on issues of NCMR’s, CAPA’s, investigations, inventory control, finance, administration and purchasing
  • Inventory management using Macola. Plan and monitor raw material and finished goods inventory to support global market demands. Month-end inventory reporting to TSI.
  • Monitor safety stock, create, assign and follow up on production orders.
  • Perform analysis of backlog items and take action as needed.
  • Plan and coordinate maintenance, repair, and calibration of all production related gauges and equipment. Maintain records of these activities. Coordinates external resources as required.
  • Assist in production as needed, final testing and final visual inspection.
  • Coordinate shipment of sales orders with TSI Customer Service to ensure delivery to schedule. Pull, verify, and pack final product for shipment in accordance with customer requests and company policies and procedures.
  • Coordinate shipments of goods authorized for customer return with TSI Customer Service and / or TSI Quality Assurance.
  • Quality Assurance control for manufacturing, adherence to Safety standards and recordkeeping such as SDS files.
  • Support all other areas as needed; Engineering, Testing, Shipping, etc.
  • Perform other work-related duties as requested, directed or assigned by management.

Education and Experience

  • Bachelor’s Degree in Biomedical Engineering with mechanical engineering emphasis. Master’s degree preferred.
  • Minimum of 3 years working in small-assembly manufacturing setting.

Knowledge, Skills and Abilities

  • Experience with 3D printing processes and ability to use 3D drawing software to create objects used in manufacturing, testing and production.
  • Good knowledge of medical materials used in long term implantations both in humans and animals.
  • Requires broad knowledge of purchasing, forecasting, distribution, inventory control, and manufacturing process controls.
  • Prior experience in a highly regulated environment such as the Pharmaceutical, Medical Device or Aerospace industries is desirable.
  • Strong organizational skills and the ability to multi-task.
  • Ability to define problems, collect data, establish facts, deal with abstract & concrete variables, and then to draw valid conclusions. Must react with a strong sense of urgency
  • Good oral and written communication skills with R&D scientists, engineers, and suppliers is required.
  • Expertise in Microsoft Word and Excel and prior experience in the use of an MRP/ERP system is required.

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Continuous Improvement Engineer
Manufacturing O/H

Ithaca, NY

This position is responsible for identifying, managing and leading continuous improvement projects for Transonic’s manufacturing processes with a goal toward improving efficiencies, reducing cost and improving quality by utilizing continuous improvement techniques.

Duties and Responsibilities:

  • Investigate, evaluate, troubleshoot and resolve production issues including material use variances, bottlenecks and inefficiencies
  • Identify opportunities and implement changes to improve manufacturing processes and to reduce costs, using knowledge of manufacturing processes, tooling and production equipment, assembly methods, quality control standards, and product design, materials and parts.
  • Apply continuous improvement methods such as lean manufacturing to enhance manufacturing quality, reliability, or cost-effectiveness.
  • Maximize efficiency by optimizing layout of equipment, workflow, assembly methods, and workflow utilization
  • Assure product and process quality by designing testing methods; testing finished process and product capabilities; establishing standards; confirming manufacturing processes.
  • Drive the implementation of Engineering Change Orders on the production floor.
  • Prepare product and process reports by collecting, analyzing, and summarizing information and trends.
  • Determine root causes of failures or quality issues and recommend changes in designs, tolerances, or processing methods.
  • Drive the standardization of processes and the implementation of metrics & best practices which will assist in meeting or exceeding Transonic’s standards for quality.
  • Provide process expertise and support to Design and Product Engineers to refine product designs to increase producibility and decrease costs related to manufacturing
  • Train Manufacturing personnel on production work instructions and process
  • Perform other work-related duties as requested, directed or assigned by management.

Education and Experience

  • B.S. in Industrial or Manufacturing Engineering with practical experience on mechanical and electronic device manufacturing process & workflow
  • Lean Six Sigma certification plus practical experience applying the tools in a production environment. Green belt certification or higher is preferred.
  • Experience in medical device industry is preferred

Knowledge, Skills and Abilities

  • Demonstrated ability to effectively manage projects and accomplish goals
  • Should possess strong organizational, project management, and influencing skills with the ability to work on multiple projects and lead multiple teams
  • Proven effective communication skills to work with shop floor personnel, technical teams and management to gain buy-in and support needed to accomplish the improvements
  • Demonstrated ability to set priorities, meet deadlines and deliver projects on time in a fast-paced environment
  • Ability to develop new training or methods of training related to production process and manufacturing work instructions.
  • Strong problem solving and analytical skills
  • Computer proficiency in Microsoft applications and capable of using other related software applications such as Macola, Crystal Reports, CRM or similar

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Production Tech I
Manufacturing - Probes & Meters

Ithaca, NY

Conducts, maintains, tests and repairs electrical/electronic, mechanical systems and components. Applies knowledge of electrical/electronics and mechanical principles in determining equipment malfunctions and applies skills in restoring equipment to operation.

Duties and Responsibilities:

  • Repair and calibration of precision medical flow sensors; recirculation and test of flow meters.
  • Troubleshoots and repairs mechanical and electrical/electronic equipment including but not limited to programmable controls, numeral controls, gages and test equipment.
  • Sets-up and operates a variety of hand-operated tools and electronic equipment to manufacture product specified on work orders using standard work instructions and Inspection procedures.
  • Documents inspection results and enters data into the devices database and other computer collection systems.
  • Plans and performs work requiring a thorough knowledge of electrical/electronic and mechanical theories and principles, writing specifications, local and national electrical codes, properties of various materials, and principles of operation and application of electronic equipment.
  • Maintains company-required performance and maintenance records for identified equipment.
  • Orders parts as required in order to complete repairs.
  • Performs preventive maintenance functions as directed.
  • Assists manufacturing personnel with technical troubleshooting.
  • Ensures clean and organized work environment at all times.
  • Manage tasks related to multiple production duties, prioritize and respond to special assigned duties.
  • Perform other work-related duties as requested, directed or assigned by management.

Education and Experience

  • High school diploma or its equivalent required.
  • Two-year technical degree or equivalent work experience in a technical field is preferred.
  • Minimum of 2 years of calibration experience preferred and the ability to demonstrate high proficiency in these areas.

Knowledge, Skills and Abilities

  • Position requires electronic and mechanical aptitude, good trouble shooting skills, customer service skills, good written and verbal communication skills and the ability to meet production deadlines.
  • Must have a strong understanding of electrical, pneumatic, temperature, electronic and mechanical measurement techniques and concepts in a high paced manufacturing environment.
  • A thorough knowledge of electronic test equipment, function generator, digital /analog multimeter, temperature instruments and equipment including the use of special instruments for diagnostic purposes.
  • Must be able to work well with all levels of personnel whether individually or in a team environment, and especially must be able to interface and communicate with co-workers in order to assist with repairs and troubleshooting.
  • Willing to work overtime as required.
  • Proficient in PCs, PC-based productivity applications, specifically, MS-Office.
  • Basic soldering skills for assembly or rework.
  • Must be safety conscious.

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Assembler I
Manufacturing - Probes & Meters

Ithaca, NY

Perform basic mechanical assembly of precision medical equipment using microscopes, variety of small hand tools, and soldering methods.

Duties and Responsibilities:

  • Assemble and test electro/mechanical precision medical products using a variety of small hand tools, epoxies and glues, soldering, and crimping techniques.
  • Set-up and operate a variety of hand-operated tools and equipment to manufacture and assemble product specified on work orders using standard work instructions and inspection procedures.
  • Follow written procedures, schematics and blueprints with a high level of accuracy to ensure all product meets company and quality specifications.
  • Document and enter data into the device history database and other computer collection systems.
  • Maintain company-required performance and maintenance records for identified equipment.
  • Perform preventive maintenance functions as required or directed.
  • Ensure a clean and organized work environment at all times that meet or exceed company standards
  • Manage tasks related to multiple production duties, assist in prioritization and respond to special assigned duties as needed to assure production deadlines and timelines are met
  • Perform other work-related duties as requested, directed or assigned by management.

Education and Experience

  • High school diploma or its equivalent required.
  • Previous work experience in a medical manufacturing environment is preferred.
  • IPC solder certification preferred

Knowledge, Skills and Abilities

  • Capable of working with small precision devices under a microscope.
  • Ability to work with various epoxies and glues.
  • Basic soldering skills for assembly or rework.
  • Good written and verbal communication skills; and the ability to read, understand and follow written instructions for production processes and assembly is required.
  • Must have good mechanical aptitude and an understanding of electrical, pneumatic, temperature, electronic and mechanical measurement techniques and concepts in a high-paced manufacturing environment.
  • Ability to interface and communicate effectively and professionally with management and co-workers is essential and must be able to work well with all levels of personnel whether individually or in a team environment.
  • Willing to work overtime as required.
  • Proficient in PCs, PC-based productivity applications, specifically, MS-Office.
  • Must be safety conscious.

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