Haemonetics · 5 days ago
Principal Product Development Engineer (Hybrid, Boston)
Boston, MA
Full-time
Hybrid
Senior Level, Lead/Staff
$101K/yr - $137K/yr
2+ years expHaemonetics is a company focused on innovative solutions in the healthcare sector. They are seeking a highly skilled Principal Product Development Engineer to contribute to the design and development of in vitro diagnostic devices, ensuring compliance with regulations and collaborating with cross-functional teams.
BiotechnologyConsultingHealth CareMedicalMedical Device
Responsibilities
Design and Development
Contribute to the development of IVD assays and devices from concept through commercialization
Work independently and apply advanced scientific principles and methods in experimental design and data interpretation
Optimize assays for sensitivity, specificity, reproducibility, and design for manufacture
Collaborate with engineering teams to integrate assays into device platforms
Verification and Validation Testing
Develop and execute verification and validation protocols in compliance with applicable regulations
Perform analytical performance studies to ensure product requirements are met
Work with the clinical science team to write clinical trial protocols and reports
Laboratory Management
Apply good laboratory practice principles to ensure R&D laboratories are well-maintained
Contribute to the management of the laboratories including tracking calibrations, environmental monitoring, safety hazards, and other tasks, as required
Cross-Functional Collaboration
Work closely with hardware/software engineers, regulatory affairs, quality assurance, basic science/service lab, scientific affairs, marketing, and manufacturing teams
Provide scientific expertise during design reviews and risk assessments
Assist the manufacturing team in solving production issues and sustaining projects through technical expertise and investigational bench testing
Exhibit highly effective communication and collaboration skills that can be applied across functions
Documentation and Compliance
Ensure adherence to quality management systems and regulatory standards
Establish, train, and maintain an easy-to-use laboratory testing documentation procedure for Boston based investigational testing
Qualification
Required
Ph.D. or M.S. in Bioengineering, Biochemistry, Analytical Chemistry, or related field required
Minimum 2-4 years in IVD development or related industry
Proven track record in proven track record in assay design & development including design optimization, device integration, verification, and transfer to production activities
Experience developing and optimizing assays on disposable microfluidic or cartridge-based platforms
Experience in reagent formulation and stabilization for microfluidic applications (small-volume drying, bead-based reagents, in-channel drying, long-term stability on plastic substrates)
Familiar with disposable microfluidic design and fabrication methods (injection molding, film lamination, laser cutting/welding, reagent deposition, adhesive/ultrasonic bonding, QC methods)
Prior success supporting 510(k), PMA, or technical file submissions
Strong knowledge of biochemical, reagent-driven, clinical diagnostics
Familiarity with regulatory requirements (FDA, CLSI, IVDR, ISO standards)
Excellent problem-solving, project management, and communication skills
Comfortable engaging with outside equipment, material, and chemical/reagent manufacturers. As well as other researchers, and engineering/scientific testing service providers
Preferred
Hands-on experience with developing assays or diagnostic platforms
Experience with data analysis software and statistical tools
DOE (multifactor, multivariate experimental design and modeling)
Benefits
401(k) with up to a 6% employer match and no vesting period
Employee stock purchase plan
Flexible time off for salaried 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
Company
Haemonetics
Haemonetics is a global medical technology company that provides Blood Management and Interventional Technologies.
1001-5000 employees
H1B Sponsorship
Haemonetics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (3)
2023 (3)
2022 (2)
2021 (4)
Funding
Current Stage
Public CompanyTotal Funding
$1.75B2024-05-21Post Ipo Debt· $600M
2021-03-01Post Ipo Equity· $435M
2019-05-23Post Ipo Equity· $10M
Leadership Team
Christopher Simon
President and Chief Executive Officer
Christopher Lindop
CFO and VP Business Development
Recent News
Silicon Republic
2026-01-14
Medical Device Network
2026-01-13
Company data provided by crunchbase