Senior Product Development Engineer -Mechanical Engineering (Hybrid Boston)

Job Summary 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. In this role, you will serve as the primary owner of the mechanical design and functional performance of disposable components used within the TEG6s in vitro diagnostic (IVD) system. You will play a critical role across the full product lifecycle—supporting both new product development and sustaining engineering initiatives—while collaborating closely with assay development, manufacturing, quality, regulatory, system hardware, clinical, and commercial teams to ensure robust product performance and successful market introduction. Your work will directly influence the accuracy, reliability, and usability of a platform used globally in clinical decision‑making. Key Responsibilities Design & Technical Leadership : 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. Execution, Testing & Compliance : 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). Cross‑Functional Collaboration & Mentorship : Partner with QA, DQ, SQ, Clinical, Regulatory, Marketing, Procurement, and Manufacturing 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. Qualifications 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. Preferred Qualifications Experience with microfluidic, cartridge‑based, or disposable diagnostic systems. Hands‑on iterative prototyping and test‑driven design experience. Proficiency with data analysis and DOE methodologies. Skills & Competencies Strong GD&T capabilities for drawing creation and interpretation. Familiarity with project management tools (MS Project, Smartsheet). Working knowledge of FDA QSR, CE Marking, and ISO quality systems. Effective collaboration with cross‑functional partners and external suppliers. Basic wet‑lab proficiency supporting testing and system development. What This Role Offers Ownership of critical components within a globally deployed diagnostic platform. Opportunities to work at the intersection of engineering, microfluidics, and clinical diagnostics. Collaboration with a highly skilled and mission‑driven technical team. Direct contribution to improving patient outcomes worldwide. EEO Policy Statement Haemonetics is an equal opportunity employer. We celebrate diversity and encourage all qualified candidates to apply. Pay & Benefits Base salary range: $78,400.00 – $133,400.00 per year. The base pay will be based on location, education, job‑knowledge, skills, and experience. In addition to compensation, the Company offers a competitive suite of benefits, including a 401(k) with up to a 6% employer match, employee stock purchase plan, flexible time off, paid sick leave, holidays, parental leave, disability insurance, tuition reimbursement, and health and welfare benefits. Eligibility for additional benefits may vary by location. #J-18808-Ljbffr Haemonetics Software Solutions