Description We are actively seeking a Senior Principal Engineer, R&D Chemistry to become an integral part of our Sensor Team at bioMerieux's San Jose site. In this pivotal role, the Senior Principal Engineer, R&D Chemistry will spearhead strategic R&D initiatives involving advanced chemistry, materials science, cross-functional engineering, and cutting-edge biosensors and diagnostics.
The Senior Principal Engineer will serve as a critical subject matter expert (SME) on bioMerieux's VITEK Reveal platform, a groundbreaking and life-saving 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 diagnostic 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 Principal Engineer, R&D Chemistry will work in a highly collaborative, cross-functional R&D environment to independently champion and lead the research, development, and launch of innovative technologies and products related to rapid AST, clinical chemistry, clinical microbiology, and other applications in infectious disease diagnostics.
The Senior Principal Engineer, R&D Chemistry will leverage their world-class skills in chemistry, materials science, analytical characterization, engineering, and biology to spearhead end-to-end R&D activities from the lab through design transfer to manufacturing and commercial launch. The Senior Principal Engineer will promote and champion best practices in R&D, rigorous scientific investigation, first-principles problem solving, and experimental design, and shall guide and mentor junior scientists and engineers as needed.
We are also looking for a candidate with an exceptional ability to engage cross-functionally with other teams including Microbiology, Software & Data Science, Hardware Engineering, Process Engineering, Manufacturing, and Quality & Regulatory Affairs (QA/RA). This candidate must have outstanding data analysis skills, both in terms of statistical analysis fundamentals and software tools (JMP, MATLAB, and/or Python), deep expertise in chemistry and materials science, and a fantastic ability to lead and navigate complex chemistry R&D projects with a strong intuition for manufacturability.
Major responsibilities include leading critical R&D projects for making fundamental improvements in the sensors for the VITEK Reveal platform, pioneering advances in analytical characterization methods, serving as the technical lead on early-stage R&D projects that involve novel applications of chemistry, materials science, sol-gels, and polymers for biosensing, and driving R&D activities of future products and supporting design transfer to manufacturing and commercialization.
PRIMARY DUTIES
- Serve as the main technical lead on multiple Sensor Team projects to make fundamental improvements in sensor performance and capabilities:
- Champion a systems mindset to understand how the sensor and sensor chemistry interfaces with other subsystems of the VITEK Reveal platform at a deep level including hardware, software, and microbiology.
- Serve as the lead investigator to strategically guide collaborative investigations with 3rd party organizations including analytical characterization labs.
- Stay up-to-speed with the latest science in sol-gel chemistry to foster innovation and development of high-value intellectual property for biosensing and diagnostic applications.
- Lead the development of characterization methods to dive deeper into understanding sensor fundamentals, and leverage characterization studies to improve sensor design.
- Spearhead innovative product development projects related to current and future products and systems:
- Serve as a key technical SME on sensor chemistry to play a pivotal role in guiding strategic product development initiatives.
- Engage with other senior leaders and technical teams at various bioMerieux sites nationally and globally to identify opportunities for accelerating development and creating new intellectual property.
- Champion the use of statistical and data analysis tools like JMP, MATLAB, and/or Python within the Sensor Team to rigorously analyze data and guide experimental design.
- Continuously strive for implementing improved strategies to streamline the R&D workflow. Plan and execute well-designed studies to establish robust pass/fail acceptance criteria for key parameters, processes, and components related to the sensor and next-gen products.
- Foster and promote a quality mindset to thoroughly document development activities in compliance with GMP, 21 CFR 820, and ISO 13485. Promote best practices in product development based on regulatory guidelines and international standards (FDA, CLSI, ISO, etc.). Conduct risk assessment activities following best practices in the medical device industry (ISO 14971).
- Plan, execute, and document critical development activities, protocols and studies related to V&V for 510(k) regulatory submissions.
- Serve as a key subject matter expert (SME) in collaboration 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 a critical role in anticipating, identifying, and mitigating risks or hazards in processes, experiments and projects.
- 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 operation, and other activities tied to lab operations (LabOps). Set and foster an exemplary standard for technical communication of results.
- Exercise excellent judgment and prioritization to solve high-impact problems, and demonstrate excellence in clearly communicating results and impacts to peers and leadership. Be accountable for project completion and maintain focus on achieving high-value objectives and project goals within a timely manner.
QUALIFICATIONS
Required: Bachelor's degree in Chemistry, Chemical Engineering, Materials Engineering, Materials Science, Biochemistry or a related field with 12 years of experience.
Preferred: PhD in discipline listed above with 5 years of experience, or MS in discipline listed above with 7 years of experience
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For candidates with a PhD, must have 5 years of industry experience, with a preference for candidates who have worked in R&D in product development roles involving chemistry for in vitro diagnostics and biosensors, or products involving advanced applications of materials science, chemistry, or polymers. -
For candidates with a MS degree must have at least 7 years of experience working in an R&D environment in product development roles in the field of in vitro diagnostics and biosensors or advanced applications of materials science and chemistry. Must have a proven track record of conducting independent research in a highly technical area within chemistry, materials science, or biosensors and diagnostics. -
For candidates with a BS degree must have at least 12 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 chemistry, materials science, or biosensors and diagnostics.
Additional Qualifications
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Must have a proven track record of successful innovation, product development, and R&D in chemistry, materials science, polymer science, or a related field. -
Must have excellent 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, JMP, or MATLAB. -
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, GC-MS, 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. -
Experience with design control regulations (21 CFR 820 and ISO 13485) is preferred. -
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 $157,500 - 196,900. 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 |
bioMerieux Inc.
retirement plan
May 03, 2024