Principal Product Development Engineer

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.
We are seeking a highly skilled and innovative
** Key Responsibilities
** Perform analytical performance studies to ensure product requirements are met.

Work with the clinical science team to write clinical trial protocols and reports.

Contribute to the management of the laboratories including tracking calibrations, environmental monitoring, safety hazards, and other tasks, as required.

Exhibit highly effective communication and collaboration skills that can be applied across functions.
** Qualifications*
* *
* Education:

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

** 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).

- ** Preferred Experience
** Hands-on experience with developing assays or diagnostic platforms.

Experience with data analysis software and statistical tools.
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* Skills:

** 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.

Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting. If you believe you may be entitled to such information by law, you may contact  Monday through Friday, 7:30 a.m. – 5 p.m. ET or email
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