Bio-Rad’s Clinical Diagnostics Group (CDG) is one of the leading global providers of tests for infectious and autoimmune disease screening, diabetes screening and monitoring, blood grouping as well as a range of reagents and software for laboratory quality control. CDG provides over 3,000 reagents, devices, and instruments for about 300 diagnostic tests to a global customer base. At Bio-Rad CDG we are building a world class global R&D capability to support our ambitious clinical diagnostics strategy and drive long term growth for the company. An important part of this transformation is the creation of a Global Systems Engineering Organization to support our existing core diagnostics platforms and to execute an exciting new product roadmap. Within this organization we have an immediate need for an experienced Staff Instrument Systems Engineer to fill a key position focused on the development and commercialization of cutting-edge in-vitro diagnostics platforms. This position will be hybrid starting in Benicia, CA and moving to Hercules, CA later this year.
- Provide technical knowledge of systems engineering principles and their application to developing cost- effective, reliable, and high-quality clinical diagnostic instrument systems that satisfy customer needs and business requirements.
- Reviews and analyzes customer, business and product requirements, analyze and model the data and derive appropriate instrument requirements and functions.
- Generates, analyzes and develops robust instrument architectures, communicating and coordinating with other cross-functional development teams with trade-off studies to balance between quality, performance, instrument cost of ownership, development cost and schedule.
- Pulls together cross functional teams to formulate instrument system requirements definition, instrument functional decomposition and requirements allocation, interface specifications, instrument architecture definition, instrument system modeling, and requirements traceability and compliance including instrument verification plans and reports.
- Lead the activities related to sub-assembly and instrument integration.
- Champion the adoption and execution of DfX principles, Systems, Reliability, Risk, Usability and Requirements engineering.
- Champion - design for manufacturability, serviceability, maintainability and other “ilities”
- Works with the development teams in identifying and recommends tools, standards and methods to drive continual Systems and Reliability Engineering improvement.
- Conducts and participates in design/project technical reviews.
- Conducts and participates in DoE, FMEAs, Hazard Analysis, Risk Management process.
- Works to ensure quality and continuously promote Right First Time.
- BS in Engineering. MS desirable.
- 8 years’ experience in the engineering/development of complex systems comprised of electromechanical, fluidics and assay/chemistry subsystems.
- IVD experience, QSR/ISO regulations & standards, risk management (ISO14971) and Usability Engineering (IEC62366) in a regulated environment.
- Ability to thrive in a multi-disciplinary team setting collaborating with senior and junior scientists and engineers.
- Demonstrated innovation and initiative in dealing with technical challenges and assignments.
- Strong focus on results and achieving goals.
- Ability to identify internal customers and use their needs and perspectives in driving decisions and activities.
- Flexible and adaptive to a rapidly changing environment.
- Strong oral and written communication skills.
- Training in Design for Excellence principals preferred.
- DFSS Green Belt or Black Belt certification is desirable.
- Proficiency with C++, Python, or Matlab
Due to the higher threat of more infectious and deadly COVID-19 variant strains emerging, Bio-Rad has a mandatory vaccination policy requiring its US employees to be fully vaccinated against COVID-19 as a condition of employment. New hires will be asked to upload their vaccination card into our electronic database hosted by ClearPass, who specializes in securing electronic medical information, within 3 days of their start date. With this policy, Bio-Rad joins a growing list of companies that are prioritizing sound science and available facts to best ensure the ongoing safety of its employees and the community.
Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 8,000 employees and a global network of operations serving our customers, we help people live longer, healthier lives.
Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.
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