Sr. Product Development Engineer

Scientific/R&D San Jose, California

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We offer an opportunity to join us at an inflection point in our commercial growth, with our first commercial product being released new venture capital funding and recognition from major customers and government agencies fueling an expansion of our staff.    
We are seeking a Senior Product Development Scientist to join the Sensor Team at bioMérieux’s San Jose site to work on the VITEK Reveal platform, a groundbreaking next-generation system for rapid antimicrobial susceptibility testing (AST). As the threat of antibiotic resistant bacteria grows, bioMérieux is at the forefront of developing faster, more accurate AST products that save lives by guiding healthcare providers towards the most effective treatment option in less time.    
As a member of the Sensor Team within the R&D Chemistry Department, the Senior Product Development Scientist will work in a highly collaborative, cross-functional R&D environment to research, develop, and launch innovative technologies related to rapid AST and other applications in infectious disease diagnostics.     
The Senior Product Development Scientist will leverage their skills in chemistry, materials science, engineering, and biology to spearhead end-to-end R&D activities from the lab through design transfer to manufacturing and commercial launch. We are looking for a candidate with an exceptional ability to engage crossfunctionally with other teams including Microbiology, Software & Data Science, Hardware Engineering, Process Engineering, and Quality & Regulatory Affairs (QA/RA). Primary responsibilities focus on making fundamental improvements in the sensors, developing improved characterization methods, defining critical specifications, guiding development activities of future products, developing design improvements for existing products, and supporting design transfer to manufacturing and commercialization.     
Essential Duties & Responsibilities    
  • 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 and  
    experiments. 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.    
Training and Education:    
Required: Bachelor’s degree in Chemistry, Chemical Engineering, Materials Engineering, Materials Science, Biochemistry or a related field. with 10 years of experience.  
PhD with 2 years + as above experience 
MS with 4 years + as above experience 
For candidates with a PhD, must have 2+ years of industry experience, with a strong preference for candidates who have worked in R&D in product development roles on in vitro diagnostics and biosensors. 
For candidates with a MS degree must have at least 4 years of experience working in an R&D 
environment in product development roles in the field of in vitro diagnostics and biosensors. Must have a proven track record of conducting independent research in a highly technical area within life sciences, diagnostics, chemistry or materials science. 
For candidates with a BS degree must have at least 10 years of experience working in an R&D 
environment in product development roles in the field of in vitro diagnostics and biosensors. Must have a proven track record of conducting independent research in a highly technical area within life sciences, diagnostics, chemistry or materials science. 
Additional Experience:  
  • 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.
The estimated salary range for this role based in California is between $136,000 and $163,000 annually. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer.     
In addition, bioMérieux offers a competitive Total Rewards package that may include:    
  • 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).