Design Assurance Engineer — Class II Medical Devices

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

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Matching

HSA/FSA

Job summary

Motion Recruitment Partners LLC in Marlborough, MA is seeking a Design Assurance Engineer to help develop and sustain advanced Class II electro-mechanical medical devices. The role emphasizes design controls, risk management, verification and validation, and regulatory compliance.

You will work across the full product development lifecycle, collaborating with Regulatory, Quality, and external testing partners to ensure tests and documentation meet FDA/ISO standards.

Qualifications

• Bachelor's Degree in Engineering or related field; Electrical 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 labs (TÜV, Intertek).
• Experience with design documentation, V&V, DFMEA/PFMEA.
• Strong 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

Electro-mechanical devices

Design Controls & Risk Management

EMC/EMI/IEC testing

V&V/DFMEA/PFMEA

Word & Excel

Cross-functional collaboration

Education

Bachelor's Degree in Engineering

Job description

Motion Recruitment Partners LLC in Marlborough, MA is seeking a Design Assurance Engineer to help develop and sustain advanced Class II electro-mechanical medical devices. The role emphasizes design controls, risk management, verification and validation, and regulatory compliance.

You will work across the full product development lifecycle, collaborating with Regulatory, Quality, and external testing partners to ensure tests and documentation meet FDA/ISO standards.