Device Development Engineer

The 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.

This role is onsite 5 days/week in the greater Boston area.

• 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.

• 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 Solid Works or similar 3D CAD software.
• Experience with Mechanical design and assemblies, Mechanical testing and verification, GD&T and technical drawings, Plastic part design, extrusion, and injection molding, Risk management (DFMEA, UFMEA), Technical transfers and process development.
• Experience working with CMOs, suppliers, and external development partners.
• Strong data analysis, problem-solving, and communication skills.