Design Assurance Engineer (Medical Devices)

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

Job summary

Motion Recruitment in Marlborough, MA is seeking a Design Assurance Engineer to join a leading global technology company. The role focuses on Class II electro-mechanical medical devices across the full development lifecycle, from design and risk assessment to verification, validation, and regulatory submissions.

The ideal candidate has 3–5 years of medical device experience, expertise in design controls, risk management, and problem-solving within cross-functional teams.

Qualifications

• Bachelor’s degree in Electrical Engineering or a related field.
• 3–5 years of Class II medical device experience.
• Experience with Design Controls and Risk Management.
• Experience with verification and validation.
• Experience with EMC, EMI, and IEC compliance testing.
• Experience with DFMEA/PFMEA and technical documentation.
• Strong communication and documentation skills.
• Proficiency with Microsoft Word and Excel.

Responsibilities

• Support design control and risk management activities.
• Perform and support DFMEA and PFMEA activities.
• Develop and execute verification and validation protocols.
• Support IQ/OQ/PQ and other validation activities.
• Coordinate EMC, EMI, and IEC compliance testing.
• Work with external test laboratories.
• Maintain design history files and technical documentation.
• Support FDA, CE, and other regulatory submissions.
• Analyze test data and help engineering teams make design decisions.
• Collaborate with Design Engineering, Quality, Regulatory, and external partners.

Skills

Design Controls & Risk Management

Verification & Validation

DFMEA/PFMEA

Technical Documentation

Communication Skills

Education

Bachelor’s degree in Electrical Engineering or related field

Tools

Microsoft Word

Microsoft Excel

Job description

Motion Recruitment in Marlborough, MA is seeking a Design Assurance Engineer to join a leading global technology company. The role focuses on Class II electro-mechanical medical devices across the full development lifecycle, from design and risk assessment to verification, validation, and regulatory submissions.

The ideal candidate has 3–5 years of medical device experience, expertise in design controls, risk management, and problem-solving within cross-functional teams.