Design Assurance Engineer — Class II Med Devices

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

Benefits offered by this job

Medical Insurance

401(k) Plan with Company Matching

Job summary

Motion Recruitment in Marlborough, MA is seeking a Design Assurance Engineer to support design controls, risk management, and regulatory compliance for Class II electro-mechanical medical devices. You will participate in FMEA and V&V activities and help prepare FDA/CE submissions.

The role requires a Bachelor’s degree in engineering and 3–5 years of related experience, with strong MS Word/Excel skills and experience with testing organizations like TÜV or Intertek.

Qualifications

• Bachelor's degree in engineering or related field; electrical engineering preferred.
• 3–5 years of Class II electro-mechanical medical device experience.
• Experience with design controls and risk management.
• Experience with medical device compliance testing (EMC/EMI/IEC).
• Experience with external testing organizations (TÜV, Intertek).
• Experience with design documentation, V&V protocols, and DFMEA/PFMEA.
• Strong Microsoft Word and Excel skills.

Responsibilities

• Support Design Controls, Risk Management, and FMEA activities.
• Plan and execute Verification & Validation activities.
• Support regulatory and compliance testing; maintain technical documentation and design records.
• Analyze test data and support engineering decisions.
• Collaborate with Design Engineering, Regulatory, Quality, and external testing teams.

Skills

Design Controls

Risk Management

Verification & Validation

Regulatory compliance

Documentation

MS Word

MS Excel

Education

Bachelor's Degree in Engineering or related field

Job description

Motion Recruitment in Marlborough, MA is seeking a Design Assurance Engineer to support design controls, risk management, and regulatory compliance for Class II electro-mechanical medical devices. You will participate in FMEA and V&V activities and help prepare FDA/CE submissions.

The role requires a Bachelor’s degree in engineering and 3–5 years of related experience, with strong MS Word/Excel skills and experience with testing organizations like TÜV or Intertek.