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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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We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice. 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…