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, 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