<img height="1" width="1" style="display:none" src="https://www.facebook.com/tr?id=875423625897521&amp;ev=PageView&amp;noscript=1">

Careers

Would You Like the Opportunity…

Make-a-Difference

...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.

Growth-02
...-for-Growth

... 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.

Quality-of-Life-2
Quality-of-Life-1

... for Quality of Life

Transonic’s headquarters is located in cosmopolitan Ithaca, NY, home to Cornell University and Ithaca College. Ithaca is situated in the beautiful Finger Lakes region where rural life and recreation interface with city sophistication and world-class culture. Click here to view  Prospective Employee Information.

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

Sort Job Listings:

Ithaca, NY, USA

Director of Engineering

View Details View Less

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:

  • Bachelor’s degree in engineering required
  • Background in science, technology, engineering, and mathematics (STEM) educational disciplines is required
  • Experience in designing medical devices is strongly preferred

Ithaca, NY, USA

Project Manager

View Details View Less

The Project Manager position is a key position in the Transonic Team in that it maintains the main project management tool at Transonic and utilizes it to lay out projects, track them, identify potential issues in resource allocations, timelines and deliverables to provide both the project and the management teams with the metrics and information required to drive both projects and the business as a whole. The Engineering PM is responsible for leading cross-functional teams in the New Product Development (NPD) and Sustaining Engineering efforts to bring new and innovative flow measurement devices from concept to commercialization in the medical device, life science and OEM industries. This role needs to be able to apply Project Management best practices, tools, methodologies and techniques to meet the needs and expectations of all stakeholders.

Duties and Responsibilities:

  • Able to learn and work within the current set of project management tools deployed within the company (Celoxis, GitLab)
  • Communicate effectively at the company executive level, the project management level and at the individual contributor level
  • Be able to effectively oversee multiple projects each held by different project managers with various degrees of PM experience. Help guide direct project management staff to effectively manage their projects - this would involve helping them to establish the needed tasks and dependencies, scheduling, required resources and working with them on time management.
  • Responsible for coordinating the daily task allocations, checking in with team leaders to advise on potential resource allocation conflicts and helping to ensure the priority of work established by the company as a whole is followed and conflicts are escalated to the management team for solutions.
  • Hold regular technical team meetings to determine progress and address any questions or challenges regarding projects.
  • Be able to handle project risk analysis and remediation to ensure overall company project goals are met.
  • Utilize the company's project management tool to design and distribute formal reporting to internal management and the company's OEM clients that are funding various projects. Reporting can included assigned project budgets, manpower utilization including shortages, skill set analysis for needed resources to rectify shortages, and scheduling issues.
  • Effectively negotiate with multiple cross company resources for timing and scheduling of resources, facilities, infrastructure, and other assets.
  • Understand the revenue impact of project management decisions taken and help guide project teams in this understanding.
  • Perform other work-related duties as requested, directed or assigned by management.

Education and Experience:

  • Bachelor's degree in Project Management or related technical field preferred. A strong working-level electronic and mechanical engineering experience would be a bonus, however the main requirement is the ability to work across various skillsets (software, firmware, hardware, electronics) to identify the technical resources needed to help understand the projects and any limitations.
  • Work experience must include demonstrable history and experience in project management or related technical leadership experience, preferably in the medical device market or a similarly highly-regulated field.
  • Project management experience with or familiarity with stage/gating processes
  • Must have experience with project scheduling tools such as MS Project or similar.
  • Professional Project Management Certification from accredited intuition preferred, such as PMP (Project Management Professional), CAPM (Certified Associate in Project Management) or similar coursework.
  • Experience mentoring, coaching, and developing rising talent in the technology department
  • Experience working in a collaborative environment and promoting a teamwork mentality
  • Managerial experience applying analytical thinking and problem-solving skills

Ithaca, NY, USA

Clinical Application Specialist

View Details View Less

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.

Ithaca, NY, USA

Software/Test Engineer - LabVIEW

View Details View Less

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.

Ithaca, NY, USA

Continuous Improvement Engineer

View Details View Less

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

Ithaca, NY, USA

Production Tech I

View Details View Less

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.

Ithaca, NY, USA

Assembler I

View Details View Less

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

Ithaca, NY, USA

Perfusion Products Manager and Application Specialist

View Details View Less

Management and support of Transonic’s Surgical and ECMO product portfolio with the primary objective being global product line growth. Responsibilities include coordination of day-to-day product portfolio management, global marketing and application support, assisting with new product development, creation of sales and end-user support materials, data analysis, and interaction with Sales and end-users as needed. Provide support to other products as needed. Interface with marketing, engineering, Quality Assurance and Regulatory Assurance, customer service, sales, end-users and business partners.

Duties and Responsibilities

Upstream Marketing:

Assist with the creation and implementation upstream marketing plans for future & existing surgical product line development. Includes: o

  • Insight – Where to play, how to win, voice of customer
  • Identity Building – Value Proposition development, Brand positioning, Brand Architecture
  • Innovation Strategy
  • Determine Product, Price, Place (distribution), Promotional Plans
  • Assist with market research to identify and develop new product and market opportunities for the surgical and ECMO product categories.

 Key Opinion Leader (KOL)Development:

  • Assist with KOL development and management for the Surgical and ECMO products and market segments
  • Identify and develop relationships with KOL’s for product evaluation, research/clinical studies, podium presentations, seminars, webinars and and educational programs

 Downstream Marketing:

  • Coordinate with Senior Management to plan promotional and communication programs/materials, trade show activities, educational programs, web-based programs, seminars and other appropriate promotional vehicles.
  • Develop and implement tactical surgical and ECMO downstream plans to generate demand and demonstrate the value proposition for the existing portfolio & drive future adoption of Transonic Flow equipment.
  • Maintain and contribute to company competitive files including product details on major competitors

 Field Support & Development:

  • Collaborate with existing & potential customers, and with sales force in novel applications for current products
  • Develop and present effective sales tools and present technical training as needed to a global network of sales personnel, distribution channels and end users
  • Participate in key sales situations for the product
  • Work in the field as needed to assist Sales personnel and to keep abreast of the latest trends and needs in the market
  • Perform other work-related duties as requested, directed or assigned by management

Working Relationships

  • Work closely and effectively with co-workers in the Marketing, Sales, Manufacturing, Quality, Engineering and R&D Departments
  • Develop, maintain and lead all aspects of strong, successful working relationships with Key Opinion leaders, existing customers, collaborators and potential customers

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
  • 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 surgical product line
  • Must be dynamic, upbeat and flexible with the ability to work in a fast-paced, diverse environment

Supervisory Responsibilities

  • No Direct Reports

Physical Demands & Work Environment

  • Must be willing to travel domestically and internationally to tradeshows, conferences and interact with sales & potential/active customers. Estimated expected travel time, cumulative, would be around 15%-25%of total work time
  • Lifting (50 lbs max) and demonstrating equipment are essential elements of this position

 

Disclaimer: This Job Description is not intended to be all-inclusive and may be subject to change to include new responsibilities and tasks or change existing ones as management deems necessary to meet the ongoing needs of the company.

Education and Experience

  • BS Degree
  • Completion of a Perfusion program and a minimum of 5 years perfusion experience
  • Perfusion background and experience

Ithaca, NY, USA

Firmware Engineer

View Details View Less

This position works closely with Engineers and develop firmware for Transonic’s cutting edge products. This position will support the firmware development and maintenance for New Product Development and Sustaining Engineering products that are used clinically as well as in research areas including: cardiovascular; surgery; interventional radiology; and other such areas.

Duties and Responsibilities
  • Design, develop, and test firmware in compliance with applicable regulations and processes.
  • Review firmware and software developed by other team members
  • Assist with firmware related documentation and the maintenance of a team wiki
  • Troubleshooting, debugging, maintaining, and supporting firmware on existing products
  • Define and implement firmware requirements and designs
  • Investigate new computer science technologies in industry and their potential applications to optimize firmware performance in current and new products
  • Participate in planning discussion that includes time and complexity estimation of team tasks
  • Work on multiple projects and drive with objectives and priority
  • Willingness to perform additional tasks as requested, directed or assigned by Management
Education and Experience
  • BS degree in Computer Science/Engineering or equivalent
  • 3+ years of industry experience with low level programming languages and embedded design principles; C preferred and GNU C is a plus

Ithaca, NY, USA

Electrical Engineer

View Details View Less

This position would be responsible for the design and development of electronic systems used in medical devices. This position will support the development efforts required for New Product Development and Sustaining Engineering for products that are used clinically as well as in research areas including: cardiovascular surgery, interventional radiology, and other such areas.

Duties and Responsibilities
  • Design and develop analog RF and digital circuits for Transonic’s medical devices which meet or exceed Company standards for quality
  • Design and develop RF, analog and digital circuit board layouts
  • Trouble shooting radio frequency circuits to the component level
  • Confirm component capabilities by designing testing methods and developing test procedures and instructions for checking electronic assemblies
  • Analyze and make recommendations for improvements in the design and layout of current electronic assemblies and implement approved improvements
  • Develop and perform verification testing of new and updated electronic assemblies ensuring adherence to Company quality standards
  • Create and update drawings and specification documents for printed circuit assemblies, electro-mechanical subassemblies, and finished medical devices.
  • Willingness to perform other work-related duties as requested, directed or assigned by management
Education and Experience
  • Bachelor’s Degree in Electrical and Electronics Engineering or similar field required
  • 2-3 years’ experience preferred
  • Familiarity and experience with programs for schematic capture, PC board layout, CAD and database programs
  • Familiarity with Altium, MultiSim, Ultiboard, and Labview a plus.
  • Experience with microcontroller programming and FPGA programming is a plus

Ithaca, NY, USA

Sensor Development Engineer

View Details View Less

We are seeking a Sensor Development Engineer who will play a critical role in the design and development of our next generation Flowprobes and Flowsensors. This will include project management of new Sensor/probe projects, user needs development, mechanical concept development, detailed design, engineering drawing creation, building of sensor prototypes, sensor testing, cost/performance optimization, the ability to use principles of design for manufacturability and transferring of final designs to manufacturing via ECO creation. This position will spearhead new designs & improvements for our existing Flowprobes & Flowsensors as well as novel OEM client work for our medical device manufacturers.

Duties and Responsibilities

  • Maintain awareness of new technologies, scientific developments, design software and hardware capabilities, as well as software tools to improve functionality of our products
  • Learn and understand the theories of measurement for our product lines, understand calibration requirements
  • Build project plans and manage time wisely for next generation design release.
  • Gather user needs and understand use cases & applications for next gen design projects
  • Occasionally work with R&D to integrate novel technologies and measurements into designs
  • Develop mechanical concepts & create engineering drawings for new Flowsensors & Flowprobes
  • Investigate and develop sensor materials and technologies to improve designs.
  • Utilize best practices of Design for Manufacturability to create new sensors at the lowest cost of manufacturing while attaining desired product functionality & robustness.
  • Build and test new sensor prototypes
  • Create Engineering Change Orders and BOMs for release to manufacturing
  • Document & train manufacturing engineering staff on build process and help create work instructions for assembly
  • Willingness to perform other duties as requested, directed or assigned by Management

Education, Experience, Skills & Abilities

  • The ideal candidate must have a strong technical aptitude
  • Experience in project management & project management software preferred
  • Knowledge of both electrical and mechanical design preferred
  • 3-5 years of applicable engineering experience
  • Working knowledge of materials such as plastics, epoxies, stainless steel, etc.
  • Working knowledge of design drafting standards
  • Proficient in 3D solid modeling software - preferably SolidWorks
  • Working knowledge of tolerances and stack-up analysis.
  • Excellent technical communication (verbal and written)
  • Working knowledge of Microsoft Office software.
  • Bachelor’s in Mechanical Engineering, Biomedical Engineering with Mechanical Engineering courses or related degree preferred

Ithaca, NY, USA

Quality Engineer

View Details View Less

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

Davis, CA, USA

Jr. Electronics and Software Design Engineer

View Details View Less

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
Education 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.

Davis, CA, USA

Manufacturing Process Engineer

View Details View Less

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.

Apply Here