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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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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Regulatory Validation Engineer
Engineering

Ithaca, NY

This position is for a degreed engineer to fill a position that will lead the company-wide process validation of all regulatory requirements for our current and future medical devices that we design and manufacture. All candidates should have a depth of experience in applicable FDA and foreign medical device regulations, including ISO 13485 and MDD 820.

We are seeking candidates that are career driven, have strong analytical and technical skills, and a depth of experience in designing and results-reporting of regulatory validation processes of medical devices.

Duties and Responsibilities:

  • Remain current on all applicable regulatory guidance and other documentation that impact the company’s ability to legally market medical devices around the world.
  • Create formal written regulatory-based documentation that can be tactically used to complete all product testing, internal and external to support FDA and foreign regulatory submittals.
  • Create formal written regulatory-based documentation that can be tactically used to complete process qualifications including Installation Qualification, Operation Qualification and Performance, IQ, OQ PQ
  • Develop, design, and execute device validation protocols.
  • Establish, coordinate and act as subject matter expert for the company’s regulatory execution plans, schedule maintenance and documentation quality and consistency.
  • Write, review, and approve validation change controls and validation protocols.
  • Perform training on regulatory procedures and updates on guidance to company personnel.
  • Facilitate the Risk Management Process in compliance to applicable external standards and corporate policies.
  • Remain current with all mandatory and recommended certifications processes as it relates to global regulatory compliance.

Education and Experience

  • Bachelor’s degree in engineering, science, or technical discipline.
  • 5+ years of progressive experience in medical device engineering
  • 3+ years’ experience in medical device regulatory guidance interpretation and facilitation into written plans
  • Experience with IQ, OQ, PQ
  • Expert level knowledge of ISO 13485, MDD 820 and MDR 2017/745, domestic FDA and international regulatory requirements and medical device registrations, design control activities for medical devices as well as direct management of FDA and notified Body inspections.
  • Experience with Class III medical devices including working knowledge of process transfer, scale up, design and manufacturing.

Knowledge, Skills and Abilities

  • Ability to work independently without close supervision.
  • Strong organizational skills. Excellent verbal and written communication skills
  • Ability to handle multiple tasks simultaneously and ability to manage project timelines.
  • Strong analytical and statistical skills
  • Excellent communication skills, oral, written, and electronic
  • Must be accurate in handling detailed information/data.
  • Must have an honest code of ethics.
  • Must have the necessary transportation to get to and from TSI office.
  • Ability to travel up to 10% of the time.
  • Proficient in Microsoft Office, Microsoft Excel and Statistical Software Package.
  • Ability to read and interpret complex engineering drawings and documentation, knowledge of GD&T including ability to read and interpret complex mechanical drawings.
  • Ability to interpret FDA and foreign regulatory guidance as it relates to software and cybersecurity and be proficient in the analysis of written product-based code to provide recommendations and summary to the company as to the compliance of the product.

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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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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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Production Tech I
Manufacturing - Probes

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

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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