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

A leading global technology company is looking for a Design Assurance Engineer to join their team in Marlborough, MA. This is a full-time opportunity supporting the development and sustaining of advanced Class II electro-mechanical medical devices, with a focus on design controls, risk management, verification and validation, regulatory compliance, and technical documentation.

This is a great opportunity for a Design Assurance Engineer with 3–5 years of Class II electro-mechanical medical device experience who wants to have a direct impact on the quality and compliance of innovative products. You’ll work across the full product development lifecycle, from FMEA and design controls through compliance testing and FDA/CE submissions. Experience with lasers and optical technologies is a plus.

Required Skills & Experience

• Bachelor's Degree in Engineering or a related scientific 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, including EMC, EMI, and IEC testing
• Experience working with external testing organizations such as TÜV and Intertek
• Experience with technical design documentation, V&V protocols, and DFMEA/PFMEA
• Strong Microsoft Word and Excel skills

Desired Skills & Experience

• Knowledge of FDA QSRs, ISO 13485, ISO 14971, and IEC standards
• Experience with Design/Process Validation and Verification, including IQ/OQ/PQ
• FDA, CE, or other regulatory submission experience
• Knowledge of statistical analysis and Minitab
• Experience with lasers and optical technologies

What You Will Be Doing

• 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

Tech Breakdown

• 30% Design Controls & Risk Management
• 25% Verification & Validation
• 20% Regulatory & Compliance
• 15% Technical Documentation
• 10% Statistical Analysis & Testing

Daily Responsibilities

• 40% Hands-On Engineering & Design Assurance
• 25% Risk Analysis & Design Documentation
• 20% Regulatory & Compliance Support
• 15% Cross-Functional Team Collaboration

The Offer

• Medical, Dental, and Vision Insurance with HSA/FSA options
• 401(k) Plan with Company Matching

Applicants must be currently authorized to work in the US on a full-time basis now and in the future.