Medical Devices Design Assurance Engineer

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 medical device products, with a focus on design controls, risk management, verification and validation, regulatory compliance, and electro-mechanical medical device technologies. You’ll work closely with Design Engineering, Regulatory teams, and external testing organizations to help bring safe, compliant products from development through market release. 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 get exposure across the entire product development lifecycle—from FMEA and design controls to compliance testing and FDA/CE submissions—while partnering with engineering and regulatory teams. Experience with lasers and optical technologies is a plus, making this an especially interesting role for someone looking to expand their experience in advanced medical device technology. Required Skills & Experience Bachelor's Degree in a scientific or engineering field; Electrical Engineering preferred 3–5 years of experience with engineering and development of Class II electro-mechanical medical devices Experience with Design Controls and Risk Management practices Experience supporting medical device compliance testing, including EMC, EMI, and IEC testing Experience working with external testing organizations such as TÜV and Intertek Experience maintaining technical design documentation, including design specifications, verification/validation protocols, and DFMEA/PFMEA Strong working knowledge of Microsoft Word and Excel Desired Skills & Experience Knowledge of FDA QSRs, ISO 13485, ISO 14971, IEC 60601, IEC 60825, IEC 62366, and IEC 62304 Experience with Process/Design Validation and Verification activities, including software validation and IQ/OQ/PQ Experience supporting FDA, CE, and other regulatory submissions Knowledge of advanced statistical methods, including hypothesis testing, DOE, ANOVA, R&R studies, capability, tolerance interval analysis, and power/sample size determinations Experience with statistical software such as Minitab Experience with lasers and optical technologies What You Will Be Doing 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 Paid vacation time accrued based on years of service Paid sick time 12 paid holidays each calendar year You will receive the following benefits: Medical, Dental, and Vision Insurance with HSA/FSA options 401(k) Plan with Company Matching Employee Stock Purchase Plan (ESPP) Tuition Reimbursement Program 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