Senior Product Development Engineer -Mechanical Engineering (Hybrid Boston) (IVD and Med Dev Exp preferred)
haemonetics · Boston, MA, US · United States · Hybrid
Pay: USD 78,400 – 133,400 a year
Posted Sep 23, 2026
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Job Details:
Job Summary: We are seeking a Senior Product Development Engineer with strong mechanical design experience to lead the design and development of disposable device components for an in-vitro diagnostic platform. This role requires hands-on ownership of plastic part design, injection molded components, design specifications, drawings, tolerance analysis, verification planning, and design transfer for high-volume disposable manufacturing. The ideal candidate will combine strong mechanical design fundamentals with experience working directly with suppliers, tooling vendors, and contract manufacturers in a regulated medical device environment.
Key Responsibilities:
• Lead mechanical design of disposable device components from concept through production, including CAD modeling, design specifications, drawings, tolerance analysis, GD&T, and verification planning.
• Design plastic components for high-volume manufacturing, with emphasis on injection molding, manufacturability, dimensional control, component robustness, cost, and scalability.
• Partner with suppliers, tooling vendors, and contract manufacturers to evaluate design tradeoffs, resolve manufacturability issues, support process validation, and transition designs into production.
• Own sustaining activities for disposable components and serve as the technical lead for manufacturing and supplier component performance issues, including design change requests.
• Develop and execute verification strategies, test protocols, engineering studies, and reports to demonstrate performance against design requirements.
• Create and maintain design control documentation, including requirements, specifications, drawings, risk documentation, design reviews, investigations, and regulatory inputs.
• Collaborate across engineering, manufacturing, quality, regulatory, procurement, and commercial teams while providing technical guidance to junior engineers and cross-functional partners.
Primary Qualifications:
• Bachelor’s degree in Mechanical Engineering , Biomedical Engineering, or a related technical discipline.
• 5+ years of product development experience in medical device , IVD, life sciences, diagnostics, or another regulated product development environment.
• Demonstrated experience with mechanical component design, plastic part design, injection molded components, high-volume disposable manufacturing, CAD, engineering drawings, verification testing, and design transfer; Proficiency with 3D CAD tools such as SolidWorks and experience with engineering drawings, BOMs, ECOs, and PLM or document control systems.
• Experience working with suppliers, tooling vendors, and contract manufacturers to…