Senior Product Development Engineer – Biomedical Engineering, Mechanical Engineering

🕒 February 24

🏢🏡 Boston – Hybrid

💵 $76.4k - $130.1k / year

⏰ Full Time

🟠 Senior

🧑‍🔧 Mechanical Engineer

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Haemonetics

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1980

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Healthcare Insurance • Pharmaceuticals

Haemonetics is a company that provides a suite of innovative medical technology solutions aimed at improving the quality, effectiveness, and efficiency of healthcare. The company focuses on optimizing operations for plasma centers, enhancing patient care in hospitals, and driving efficiency in blood centers by offering advanced technologies that improve productivity, quality, and safety. Haemonetics is committed to advancing healthcare standards and creating better outcomes for patients through their technology and services.

📋 Description

• 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