Haemonetics

Senior Product Development Engineer – Biomedical Engineering, Mechanical Engineering

Haemonetics

full-time

Posted on:

Location Type: Hybrid

Location: Boston • Massachusetts • United States

Visit company website

Explore more

✨ AI Apply
Apply

Salary

💰 $76,434 - $130,147 per year

Job Level

Senior

About the role

  • Lead the complete lifecycle of disposable device components, including concept development, detailed design, integration, and verification.
  • Translate user and system needs into engineering requirements, specifications, and risk documentation.
  • Address complex design challenges balancing innovation, manufacturability, and timeline constraints.
  • Develop and execute verification and validation (V&V) test protocols; analyze performance data to confirm design functionality.
  • Plan and conduct feasibility and prototype studies supporting both new development and sustaining efforts.
  • Ensure compliance with internal SOPs and external standards including FDA QSR, CE Marking, and ISO requirements.
  • Generate high-quality documentation for design controls, investigations, and regulatory submissions (510(k), PMA, technical files).
  • Partner with cross-functional teams to support product success.
  • Provide mentorship and technical guidance to junior engineers.
  • Work directly with global suppliers to support part development, validation, and production.

Requirements

  • Bachelor’s degree in Bioengineering, Mechanical Engineering, or related technical field
  • Minimum of 5+ years in medical device, IVD, or regulated industry product development
  • Strong experience developing disposable components or capital equipment through full lifecycle (concept → production)
  • Expertise in design for high-volume manufacturing, cost optimization, and tolerance analysis
  • Proficiency with SolidWorks CAD, BOM management, and PLM systems
  • Knowledge of plastics and metals fabrication (injection molding, lamination, laser welding, additive manufacturing, bonding)
  • Prior involvement in FDA 510(k), PMA, or CE submission processes
Benefits
  • 401(k) with up to a 6% employer match and no vesting period
  • Employee stock purchase plan
  • Flexible time off
  • Vacation accrual of three to five weeks annually (based on tenure)
  • Accrual of up to 64 hours of paid sick time annually
  • Paid and/or floating holidays
  • Parental leave
  • Short- and long-term disability insurance
  • Tuition reimbursement
  • Health and welfare benefits
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
design for high-volume manufacturingcost optimizationtolerance analysisverification and validation (V&V)concept developmentdetailed designintegrationperformance data analysisdisposable components developmentprototype studies
Soft Skills
mentorshiptechnical guidancecross-functional collaboration
Certifications
Bachelor’s degree in BioengineeringBachelor’s degree in Mechanical EngineeringFDA 510(k) submissionPMA submissionCE Marking compliance