Sr. Product Development Engineer
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Description
- Work as a technical lead on Sensor Team projects to make fundamental improvements in sensor performance and capabilities:
- Acquire deep understanding of current product chemistry
- Embrace systems mindset to understand how the sensor interfaces with other subsystems of the VITEK Reveal platform including hardware, software, and microbiology.
- Develop characterization methods to dive deeper into understanding sensor fundamentals, and leverage characterization studies to improve sensor design.
- Read, analyze, and interpret scientific and technical journal publications to guide improvements in sensor design.
- Plan and execute well-designed experiments (DOE) to establish robust pass/fail acceptance criteria for key parameters, processes, and components related to the sensor Work on product development projects related to current and future products and systems:
- Leverage statistical and data analysis tools like JMP, MATLAB, and/or Python (NumPy, Pandas, Matplotlib) to rigorously and efficiently analyze data and guide experimental design
- Work with a quality mindset to thoroughly document development activities in compliance with GMP, 21 CFR 820, and ISO 13485
- Conduct risk assessment activities following best practices in the medical device industry (ISO 14971)
- Plan, execute, and document critical protocols and studies related to V&V for 510(k) regulatory submissions
- Read, comprehend, and implement best practices from regulatory guidelines and international standards (FDA, CLSI, ISO, etc.)
- Work with other teams within the Chemistry R&D Department to develop and recommend new formulations, components, methods, and technologies to achieve cost-effectiveness and improved product quality for existing and future products
- Lead investigations and complex experiments, as well as protocol and process development, optimization, revision, and execution. Play an active role in anticipating, identifying, and mitigating risks or hazards in processes, experiments and projects.
- Use data and critical thinking to evaluate performance and/or deficiencies in products andexperiments. Propose strategies and solutions for technical and operational issues when deficiencies are identified.
- Act as an exemplary lab and team member. Proactively teach, coordinate, collaborate, and communicate with supervisors and peers within and across teams and functional groups for lab activities, cleaning, equipment use, and other activities tied to lab operations (LabOps)
- Exercise good judgment and prioritization in time and task management, experimental design and execution, and presentation of results and outcomes to peers and leadership. Be accountable for task completion and maintain focus on achieving high impact objectives and project goals within a timely manner.
- Demonstrate proficiency in written and oral communication of results, study protocols and reports.
- Demonstrate technical proficiency, scientific creativity, collaboration with others, and independent thought.
- Must have solid foundations in chemistry, materials science, physics, biology, and engineering principles, and a proven track record of applying first principles reasoning to solving challenging technical problems.
- Must have excellent mathematical foundations in statistical data analysis and experimental design.
- Strong preference for candidates with high proficiency in Python for data analysis (NumPy, Pandas, Matplotlib, etc.).
- Experience with quantitative image processing (OpenCV in Python and/or Image Processing Toolbox in MATLAB) is highly valued, but not required.
- Strong preference for candidates with experience with sol-gel chemistry and colorimetric sensors.
- Strong preference for candidates with broad experience in various spectroscopic and analytical techniques for chemical analysis (UV/Vis, HPLC-MS, FTIR, rheology, polymer characterization, etc.).
- Prior experience designing and/or configuring custom hardware or instrumentation, particularly for gas-flow systems, is highly valued, but not required.
- Must have experience with design control regulations (21 CFR 820 and ISO 13485).
- Strong preference for candidates with exposure to the full lifecycle of R&D from early feasibility through
- V&V and design transfer to manufacturing.
- A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
- Company-Provided Life and Accidental Death Insurance
- Short and Long-Term Disability Insurance
- Retirement Plan including a generous non-discretionary employer contribution and employer match.
- Adoption Assistance
- Wellness Programs
- Employee Assistance Program
- Commuter Benefits
- Various voluntary benefit offerings
- Discount programs
- Parental leaves
BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).