Senior Product Development Engineer – Biomedical Engineering, Mechanical Engineering

Role Overview

• 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