Senior Product Develompent Engineer

We are seeking an experienced and creative-thinking Senior Biomedical Product Development Engineer to join our multidisciplinary Research & Development Systems Engineering team in Boston, MA. The role involves designing and developing disposable components for a globally used diagnostic platform, collaborating with cross-functional teams, and ensuring compliance with internal and external standards.

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
• Employee stock purchase plan
• Flexible time off
• Vacation annually
• Paid sick time
• Paid and/or floating holidays
• Parental leave
• Short- and long-term disability insurance
• Tuition reimbursement
• Health and welfare benefits