Design Assurance Engineer ​/ Class II Medical Devices

Design Assurance Engineer / Class II Medical Devices

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.

Specialization:
Mechanical Engineering