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Manager, Systems Engineering

Responsibilities:

  • Provide proactive leadership of the Systems Engineering team in the execution of multi-year instrument platform development and commercialization activities.
  • Work with your group as part of a cross-functional team as the Subject Matter Experts on all Systems Engineering-related matters from concept and architecture through development and commercialization including:
    • Design input requirements and specifications.
    • FMEAs and Risk Management.
    • Driving alignment between subsystem plans and design input requirements.
    • Define usability evaluation plans and testing to meet international standards.
    • System safety risks to comply with ISO 14971.
    • Verification and validation design and execution.
    • Design for Reliability and achievement of platform reliability goals.
  • Build and cultivate a results-oriented culture of innovation, empowerment, risk tolerance, learning and continuous improvement across the group. Build and maintain effective cross-functional collaborations within Bio-Rad and with external partners.
  • Work closely with the R&D and Engineering Leadership teams to drive and continually expand the functional excellence of the entire engineering team through mentorship and training.

Qualifications:

  • Bachelor s degree in engineering (mechanical, electrical/electronics, biomedical). Master s degree preferred.
  • 8+ years' systems engineering experience leading and supporting multidisciplinary teams, external development partners, and manufacturing partners.
  • 5+ years in building and managing high-performance engineering teams.
  • Strong background in system design and validation of complex medical devices (programmable electromechanical systems). IVD experience including experience with clinical diagnostic assays preferred.
  • Experience working in FDA regulated environment with knowledge of 21 CFR 820 Part 11.
  • Knowledge of FDA QMS requirements, ISO-13485, European Medical Device Regulations and Canadian Medical Devices Regulations.
  • Experience with hardware and software interfaces, as well as hardware and software architecture, is required.
  • Knowledge of lifecycle management tools such as JAMA is required.
  • Experience with Design for Reliability preferred.
  • Knowledge of Agile principles of hardware engineering is preferred.
  • Willingness to travel up to 20% domestically and/or internationally.

Manager, Systems Engineering

Gateway Recruiting
Benicia, CA
Full Time

Published on 11/25/2021

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