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. #J-18808-Ljbffr Motion Recruitment Partners LLC