Product Development Engineer (Hybrid Boston)

Haemonetics • Boston, MA

3d • $66,464 - $113,159 • Hybrid

About The Position

Haemonetics is seeking a Product Development Engineer to support the design, testing, and verification of assays within a disposable cartridge used in a regulated In Vitro Diagnostic (IVD) platform, as a member of the Research and Development Systems Group. This role is execution-focused and highly hands-on, working under the guidance of senior engineers to translate user needs and product requirements into viable design solutions, helping to develop and test new design concepts anddesign improvements. The focus of this position will be to evaluate and develop novel assay designs for an established In Vitro Diagnostic platform to drive innovative solutions to complex issues. Activities include generation of prototypes, execution of feasibility evaluations and design verification & validation testing, contributing to risk assessments, and documenting selected design solutions. The position emphasizes rigorous application of experimental design, data analysis & interpretation, and clear communication of results, while building foundational experience in regulated medical device development. This position will support both sustaining activities and new product development. The Product Development Engineer is Hybrid onsite in our 125 Summer Street NA HQ with substantial bench-level and laboratory activity

Requirements

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field
• 1–3 years of experience in product development, test engineering, or R&D (internships and co-ops applicable)
• Hands-on experience with prototyping, testing, and data analysis
• Experience in a laboratory setting
• Ability to design and execute experiments and interpret results critically
• Strong written and verbal communication skills, including technical presentation of data
• Must be tolerant to change, ready to take on new challenges and open to learning new skills.

Nice To Haves

• Master’s degree preferred in an engineering or life-sciences discipline
• Experience in regulated product development (medical device, diagnostics, or similar)
• Hands-on experience with developing assays or diagnostic platforms.
• Exposure to verification and validation practices and design control processes
• Working knowledge of statistical analysis and data visualization tools

Responsibilities

• Develop and execute hypothesis-driven test plans and protocols to test complex in-vitro diagnostic systems
• Create and maintain development documentation, including but not limited to product requirements, design descriptions, test plans, test protocols, and test summary reports
• Analyze test data, interpret results, draw technically sound conclusions, and define clear next steps based on evidence.
• Prepare concise summaries of results suitable for design reviews and decision-making in a timely manner.
• Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions to problems with broad scope and complexity
• Conduct activities in compliance with laboratory safety, good laboratory practices, and design control requirements
• Contribute to laboratory maintenance, including tracking calibrations, environmental monitoring, safety hazards, and other tasks, as required.

Benefits

• a 401(k) with up to a 6% employer match and no vesting period
• an employee stock purchase plan
• “flexible time off” for salaried employees and, for hourly employees, accrual of three to five weeks’ vacation annually (based on tenure)
• accrual of up to 64 hours (annually) of paid sick time
• paid and/or floating holidays
• parental leave
• short- and long-term disability insurance
• tuition reimbursement
• health and welfare benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 501-1,000 employees