Lead Medical Device Design Engineer (Disposable Components)

haemonetics; Boston (MA); On-site; USD 78,000 - 133,000; Full time

Benefits offered by this job

401(k) up to 6% match

Employee stock purchase plan

Flexible time off (salaried)

Paid vacation (hourly)

Paid sick time

Paid holidays

Disability insurance

Tuition reimbursement

Health and welfare benefits

Job summary

Haemonetics is seeking a Senior Product Development Engineer 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, design specs, drawings, tolerance analysis, and verification planning for high‑volume manufacturing.

The ideal candidate has 5+ years in regulated medical device product development, with hands‑on CAD (SolidWorks) and design transfer experience, plus strong supplier

Qualifications

• Minimum 5+ years of medical device product development experience.
• Strong experience with injection-molded components and high-volume manufacturing.
• Proficiency with SolidWorks and engineering drawings.
• Experience collaborating with suppliers and contract manufacturers.

Responsibilities

• Lead mechanical design of disposable device components from concept through production, including CAD modeling, drawings, tolerance analysis, GD&T, and verification planning.
• Design plastic components for high-volume manufacturing with emphasis on injection molding, manufacturability, dimensional control, robustness, cost, and scalability.
• Partner with suppliers, tooling vendors, and contract manufacturers to evaluate design tradeoffs, resolve issues, support process validation, and transition to production.
• Own sustaining activities for disposable components and lead manufacturing/supplier performance issue investigations and design changes.
• Develop and execute verification strategies, test protocols, engineering studies, and reports to show performance against requirements.
• Create and maintain design control docs including requirements, specs, drawings, risk docs, and regulatory inputs.
• Collaborate across engineering, manufacturing, quality, regulatory, procurement, and commercial teams, guiding junior engineers.

Skills

Mechanical design

Medical device development

3D CAD (SolidWorks)

Engineering drawings

BOMs/ECOs/PLM

Supplier collaboration

Education

Bachelor’s degree in Mechanical/Biomedical Engineering

Tools

SolidWorks

PLM systems

Job description

Haemonetics is seeking a Senior Product Development Engineer 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, design specs, drawings, tolerance analysis, and verification planning for high‑volume manufacturing.

The ideal candidate has 5+ years in regulated medical device product development, with hands‑on CAD (SolidWorks) and design transfer experience, plus strong supplier