Principal Product Development Engineer
Haemonetics
full-time
Posted on:
Location Type: Hybrid
Location: Boston • Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $101,074 - $136,586 per year
Job Level
Lead
About the role
- 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
- 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
- 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
- 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
- Exhibit highly effective communication and collaboration skills
Requirements
- 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 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
Benefits
- 401(k) with up to a 6% employer match and no vesting period
- Employee stock purchase plan
- "Flexible time off" for salaried employees
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
IVD assay developmentexperimental designdata interpretationassay optimizationverification protocolsvalidation protocolsanalytical performance studiesreagent formulationmicrofluidic applicationsdisposable microfluidic design
Soft skills
communication skillscollaboration skillsscientific expertiseindependent workeffective teamworkproblem-solvingorganizational skillsattention to detailrisk assessmentlaboratory management
Certifications
Ph.D.M.S.