Design Assurance Engineer, Medical Devices

Motion Recruitment; Marlborough (MA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, Dental, Vision Insurance

401(k) Plan with Company Matching

Employee Stock Purchase Plan (ESPP)

Tuition Reimbursement

Job summary

Motion Recruitment is assisting a global technology company in Marlborough, MA to recruit a Design Assurance Engineer for full-time work. The role focuses on design controls, risk management, verification/validation, and regulatory compliance across electro-mechanical medical devices.

The ideal candidate has 3–5 years of Class II medical device experience, with exposure to FDA/CE submissions and external testing collaborations.

Qualifications

• Bachelor's degree in a scientific or engineering field; Electrical Engineering preferred.
• 3–5 years of experience with engineering and development of Class II electro-mechanical medical devices.
• Experience with Design Controls and Risk Management practices.
• Experience supporting medical device compliance testing, including EMC, EMI, and IEC testing.
• Experience working with external testing organizations such as TÜV and Intertek.
• Experience maintaining technical design documentation, including design specifications, verification/validation protocols, and DFMEA/PFMEA.
• Strong working knowledge of Microsoft Word and Excel.

Responsibilities

• Perform hands-on design assurance activities across the product lifecycle.
• Lead risk analysis and design documentation efforts.
• Support regulatory submissions and compliance activities.
• Collaborate with design, regulatory, and testing partners.
• Maintain detailed design files and verification/validation records.

Skills

Design Controls

Risk Management

EMC/EMI testing

Medical device documentation

FMEA/PFMEA

MS Word/Excel

Education

Bachelor's degree in engineering or science

Job description

Motion Recruitment is assisting a global technology company in Marlborough, MA to recruit a Design Assurance Engineer for full-time work. The role focuses on design controls, risk management, verification/validation, and regulatory compliance across electro-mechanical medical devices.

The ideal candidate has 3–5 years of Class II medical device experience, with exposure to FDA/CE submissions and external testing collaborations.