NPD Engineer

Senior Medical Device Engineer ( NPD Engineer)Location: Boston, MARate: $52-59/hr on W2Client: Medical Device Manufacturer Duration: 6+ MonthsPosition SummaryThe Senior Medical Device Engineer will support the development and commercialization of drug delivery devices and combination products within Pharmaceutical Development.This role is focused on hands-on engineering execution, including device design, testing, risk management, technical transfers, and manufacturing support.The engineer will work closely with cross-functional teams and external partners to advance products from development through clinical and commercial manufacturing.Location:This role is onsite 5 days/week in the greater Boston area.Responsibilities• Design and develop medical device components, mechanical assemblies, and packaging systems.• Lead design verification and validation (V&V), feasibility studies, prototyping, and laboratory testing activities.• Generate design outputs including technical drawings, specifications, test protocols, and technical reports.• Execute risk management activities including DFMEA and UFMEA assessments.• Support manufacturing scale-up, technical transfers, process development, and GMP clinical manufacturing activities.• Collaborate with Quality, Regulatory, Human Factors, Manufacturing, and external suppliers/CMOs to ensure successful product development and compliance.• Develop and maintain technical documentation supporting FDA, EU, and ISO regulatory requirements.• Communicate project status, technical findings, and milestone progress to project teams and management.Qualifications• BS or MS in Mechanical Engineering, Biomedical Engineering, or related discipline.• 8+ years of medical device product development experience.• Strong knowledge of Design Controls, product realization processes, and applicable regulations/standards (ISO 13485, ISO 14971, IEC 62366).• Proficiency with SolidWorks or similar 3D CAD software.Experience with:o Mechanical design and assemblieso Mechanical testing and verificationo GD&T and technical drawingso Plastic part design, extrusion, and injection moldingo Risk management (DFMEA, UFMEA)o Technical transfers and process development• Experience working with CMOs, suppliers, and external development partners.• Strong data analysis, problem-solving, and communication skills.