Product Safety Engineer

Senior Product Safety & Compliance Engineer, Medical Devices Location: Greater Boston area Employment Type: Contract, Contract-to-Hire Work Arrangement: Onsite About the Opportunity The team at EDGE has partnered with a client who is seeking a hands-on Product Safety & Compliance Engineer to support product certification, regulatory compliance, and risk management across medical devices, consumer products, and commercial electromechanical products. This role partners with global product development teams, Quality, and external certification agencies to support new product development from concept through production. The ideal candidate brings an engineering background, practical product development experience, and the ability to navigate safety standards, certification requirements, and regulatory processes while working closely with cross-functional teams. Key Responsibilities Lead product certification, regulatory compliance, and risk analysis across multiple new product development projects. Support FDA-regulated medical devices, including FDA 510(k) submissions, EU Medical Device Regulation (MDR) requirements, technical files, design dossiers, and Design History Files (DHF). Apply design controls and quality standards, including FDA 21 CFR Part 820 and ISO 13485. Conduct risk management activities, including hazard analysis, DFMEA, risk mitigation, and residual risk documentation in accordance with ISO 14971. Drive usability engineering and evaluation planning in accordance with IEC 62366-1. Coordinate certification schedules, test laboratories, sample builds, budgets, and external certification partners. Collaborate with Engineering, Quality, Industrial Design, Supply Chain, and Marketing throughout the product development lifecycle. Provide technical guidance on electrical safety, electromagnetic compatibility (EMC), biocompatibility, software lifecycle compliance, and home healthcare devices. Support post-market surveillance and complaint handling under applicable FDA and EU MDR requirements. Lead project reviews and provide technical guidance to junior engineers on product certification and regulatory compliance. Required Qualifications Bachelor's degree in Engineering, such as Electrical, Mechanical, Biomedical, Systems, Materials, or a related discipline. An engineering degree is required. Experience in product design, safety, certification, or compliance involving consumer, commercial, or medical electromechanical products. Hands-on experience supporting electromechanical products through design, agency testing, certification, and regulatory submission from concept through production. Knowledge of applicable medical device regulations and standards, including: IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-11 ISO 14971 and ISO 13485 IEC 62366-1 and IEC 62304 ISO 10993 FDA 21 CFR Part 820 and FDA 510(k) EU MDR 2017/745 Experience with DFMEA, hazard analysis, risk controls, and residual risk documentation. Strong project coordination, technical problem-solving, and cross-functional communication skills. Preferred Qualifications Experience working directly with the FDA, Notified Bodies, or accredited testing laboratories. Familiarity with international regulatory requirements, including Health Canada, TGA Australia, and ANVISA Brazil. Specialized knowledge in biomedical or systems engineering, materials compliance (REACH/RoHS), biocompatibility, or embedded software compliance. Regulatory Affairs Certification (RAC). WE ARE NOT WORKING WITH THIRD PARTY AGENCIES ON ANY #J-18808-Ljbffr