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.

Key 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.

This is an on-site position with substantial bench-level and laboratory activity.

Qualifications

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

• Experience:

• 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.

• Preferred Experience

• Hands-on experience with developing assays or diagnostic platforms.

• Experience with data analysis software and statistical tools.

• DOE (multifactor, multivariate experimental design and modeling)

• 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.

• Comfortable engaging with outside equipment, material, and chemical/reagent manufacturers. As well as other researchers, and engineering/scientific testing service providers.