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 TV 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.