Principal Product Development Engineer

Haemonetics•Boston, MA

54d•$101,075 - $136,587•Onsite

About The Position

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice. Job Details Position Summary We are seeking a highly skilled and innovative Principal Product Development Engineer to join a team of scientists and engineers located in our Boston, MA Research and Development Systems Engineering Laboratory contributing to the design and development of an in vitro diagnostic (IVD) device. This role involves applying advanced scientific principles and creating reliable, accurate, and regulatory-compliant clinical diagnostic solutions in whole blood hemostasis testing. The focus of this position will be to evaluate and develop novel assay designs to drive innovative solutions to complex issues. This individual will be both a leader and collaborator within the multidisciplinary development project team to ensure timely and proficient completion of projects in a fast-paced and evolving environment. The ideal candidate will have a strong background in bioengineering, biochemistry, analytical chemistry, or similar fields combined with experience in assay development and device integration.

Requirements

Ph.D. or M.S. in Bioengineering, Biochemistry, Analytical Chemistry, or related field.
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.

Nice To Haves

Hands-on experience with developing assays or diagnostic platforms.
Experience with data analysis software and statistical tools.
DOE (multifactor, multivariate experimental design and modeling)

Responsibilities

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, as required.
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.
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.

Benefits

Incentives may also be provided as part of Haemonetics’ employee compensation.
For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms.
For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms.
Employees may also be eligible to participate in the Company’s long-term incentive plan, with eligibility and target amount dependent on the role.
In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, 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, and/or health and welfare benefits.

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