Design Assurance Engineer / Class II Medical 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

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 testingMaintain 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.