New

Sr. Product Development Scientist

bioMerieux Inc.
retirement plan
United States, California, San Jose
Apr 25, 2025
Description bioMerieux is a pioneering force in the medical microbiology device industry. Our cutting-edge technologies have been transforming healthcare and improving patient outcomes. We are seeking a Senior Product Development Scientist to join the Sensor Chemistry Team at bioMerieux'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, bioMerieux is at the forefront of developing faster, more accurate AST products and other diagnostics 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, 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, with a particular focus on chemistry, developing improved characterization methods, defining critical specifications, guiding development activities of future products, developing improvements for existing products, and supporting design transfer to manufacturing and commercialization. Primary Duties: 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 a 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 Work on product development projects related to current and future products and systems: Plan and execute well-designed experiments (DOE) to establish robust pass/fail acceptance criteria for key parameters, processes, and components related to the sensor 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 releated to developing new formulations, processes, or analytical methods. 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. Minimum Qualifications: PhD, in Chemistry, Chemical Engineering, Materials Engineering, Materials Science, Biochemistry, or a related discipline. PLUS 1+ years of experience in Product Development roles, with a strong preference for candidates who have worked in R&D in product development roles on in vitro diagnostics and biosensors. A relevant postdoc position may be considered in lieu of direct industry experience. OR MS degree in Chemistry, Chemical Engineering, Materials Engineering, Materials Science, Biochemistry, or a related discipline. PLUS 4+ years of experience in Product Development roles, with a strong preference for candidates who have worked in R&D in product development roles on in vitro diagnostics and biosensors. Strong preference will be given to candidates with direct experience in in vitro diagnostics, biosensors, chemical sensors, or a related field. OR BS degree in Chemistry, Chemical Engineering, Materials Engineering, Materials Science, Biochemistry, or a related discipline. PLUS 6+ years of experience in Product Development roles, with a strong preference for candidates. Strong preference will be given to candidates with direct experience in in vitro diagnostics, biosensors, chemical sensors, or a related field. Preferred Qualifications: Excellent mathematical foundations in statistical data analysis and experimental design, such as formal hypothesis testing, probability distributions, ANOVA, etc. is preferred. High proficiency in Python for data analysis (NumPy, Pandas, Matplotlib, Streamlit, etc.). Experience with quantitative image processing (in Python or MATLAB) is preferred. Experience with sol-gel chemistry and colorimetric sensors is preferred. Broad experience in various spectroscopic and analytical techniques for chemical analysis (UV/Vis, HPLC-MS, FTIR, rheology, polymer characterization, etc.) is preferred. Experience designing and/or configuring custom hardware or instrumentation, particularly for gas-flow systems, is preferred. Experience with design control regulations (21 CFR 820 and ISO 13485) is preferred. Exposure to the full lifecycle of R&D from early feasibility through V&V and design transfer to manufacturing is preferred. The estimated salary range for this role based in California is between $108,400 - 133,900. 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, bioMerieux 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