Senior Mechanical Engineer - Disposable Medical Devices

Haemonetics Corp; Boston (MA); On-site; USD 80,000 - 133,000; Full time

Benefits offered by this job

401(k) matching

Employee stock purchase plan

Flexible time off

Paid time off

Job summary

Haemonetics Corp is seeking a Senior Product Development Engineer in the Boston area to lead the design and development of disposable device components for an in-vitro diagnostic platform. You will own plastic part design, injection-molded components, drawings, and design transfer for high-volume manufacturing.

The role requires hands-on ownership, collaboration with suppliers and contract manufacturers in a regulated medical device environment, and strong CAD/ GD&T expertise.

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related technical discipline.
• 5+ years of product development experience in medical device, IVD, life sciences, diagnostics, or another regulated product development environment.
• Experience with mechanical component design, plastic part design, injection molded components, high-volume disposable manufacturing, CAD, engineering drawings, BOMs, ECOs, and PLM or document control systems.
• Experience with suppliers, tooling vendors, and contract manufacturers to support part qualification, manufacturing transfer, and production issue resolution.

Responsibilities

• Lead mechanical design of disposable device components from concept through production, including CAD modeling, design specifications, drawings, tolerance analysis, GD&Ts, 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.

Skills

Mechanical component design

Injection molding

3D CAD (SolidWorks)

Engineering drawings & BOMs

PLM / document control

Supplier collaboration

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

PLM systems

ECNs/ECOs

Job description

Haemonetics Corp is seeking a Senior Product Development Engineer in the Boston area to lead the design and development of disposable device components for an in-vitro diagnostic platform. You will own plastic part design, injection-molded components, drawings, and design transfer for high-volume manufacturing.

The role requires hands-on ownership, collaboration with suppliers and contract manufacturers in a regulated medical device environment, and strong CAD/ GD&T expertise.