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Senior Device Engineer

  • Billerica, Massachusetts
  • Manufacturing
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, we’d 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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