Senior Device Engineer

We are seeking a Senior Device Engineer for a direct-hire opportunity in Billerica, MA . This role will support medical device engineering, product development, testing, and technical problem-solving in a regulated environment.

If you have 7+ years of medical device and pharmaceutical experience, knowledge of QSR/GMP regulations, and SolidWorks experience, wed love to hear from you. Apply today!

Full-time Onsite
Direct Hire
Pay Rate: DoE

Job Summary:
This position provides mechanical and electromechanical engineering for sustaining engineering support for existing medical products as well as new projects.

Area Of Responsibility:

- Provide support for existing products, product investigations, and analysis to determine root cause and appropriate resolution of product issues, and support customer requirements

- Prepare and maintain all necessary product documentation including product specifications, bills of material, hazard/risk analysis, test procedures, and associated validations and procedures and support of suppliers and contract manufacturers

- Perform and complete mechanical tests and or experiments to assure designs meet industry standards, safety margins, reliability goals and international electrical and emission standards as appropriate

- Participate in project teams and assist with project plan definition, estimation, scheduling, tracking, and reporting for related projects

- Ensure that all aspects of the quality system are a high priority in all activities (e.g., design and development activity, validation protocols, risk assessment, etc.)

- Develop specifications, packaging, labeling and all associated design control documents in accordance with project, industry and regulatory requirements

- Contribute to new and supplemental regulatory submissions

- Train and/or provide direction to technicians; may train manufacturing personnel and/or suppliers when required

- Contribute ideas or generate Intellectual Property submissions

- Other duties as assigned

Performs all principle duties that affect the quality of products and services provided by the company within the guidelines of 21 CFR 210/211, 21 CFR 820, ISO 13485, the Canadian Medical Devices Regulation (CMDR), Medical Device Directive (MDD) and other applicable standards, laws and regulations wherever we do business.

Work Conditions:

- Office

- Lab

- Manufacturing area/clean room area

- Maintenance Shop

- Exposure to noise, hot and cold, outside elements, some radiation

Physical Requirements:

- Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, talk, hear, taste or smell

- Close, distance and peripheral vision; depth perception, ability to focus

- Ability to operate production equipment and hand tools

- Operate hand truck

- Operate computer/office equipment

- Wear proper lab gowning and safety shoes

- Lifting and moving of heavy boxes/equipment up to 70 lbs.

Travel Estimate: Up to 10%

Qualification:

- BS in Mechanical Engineering preferred; Associates in Mechanical Engineering or relevant experience will be considered

- 7 years of experience in the medical device and pharmaceutical industry required

- Ability to interpret and resolve technical and design issues required

- Familiar with QSR / GMP regulations

- Experience with Microsoft Office Tools and Solid Works required

Our client offers a competitive compensation package as well as an excellent benefits package for eligible candidates.

Please visit us at https://www.prostaffworkforce.com/ to explore all opportunities.

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