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Engineer IV

Engineer IV

  • 2020-16930
  • Benicia, California, United States

Bio-Rad Laboratories is looking for a seasoned Systems Engineer for the Clinical Diagnostics Group system platforms. This is a critical position to support cross-functional project teams and all efforts required for successful development.

Responsibilities

  • Support cross functional project teams and work as a systems engineering subject matter expert to evaluate, architect, develop and commercialize new products.
  • Develop design input requirements and design specifications consistent with company guidelines, regulations, and user needs and manage the subsystem extrapolations and implementations of those requirements.
  • Lead the development of FMEAs and product risk files. Support the development of design specifications and HMI specifications.
  • Work with design engineers to define requirements and design specifications, and drive alignment between subsystem plans and design input requirements.
  • Manage human factors usability risks in compliance with IEC 62366.
  • Manage system safety risks in compliance with ISO-14971.
  • Support and oversee efforts to achieve reliability goals for platforms.
  • Establish a common understanding among team members on technical approach, scope, and risk.
  • Lead system verification and validation testing design and execution to ensure product performance meets requirements.
  • Design Integration testing and roadmap in collaboration with Project Management to ensure successful adherence to time management and key milestones.
  • Manage key external resources to ensure compliance and expectation.

Qualifications

  • Bachelor’s degree in Engineering (Mechanical, Electrical/Electronics, Biomedical). Master’s degree preferred.
  • Ability to effectively communicate and translate across functions including design engineering, marketing, software, Regulatory and other global teams.
  • Must have a high level of self-discipline, drive, and a proven ability to lead teams.
  • Ability to integrate global standards and regulations into design.
  • 5+ years' systems engineering experience leading and supporting multidisciplinary teams, external development partners, and manufacturing partners.
  • Strong background in system design and validation of complex medical devices (programmable electromechanical systems). IVD experience preferred.
  • Experience working in FDA regulated environment with knowledge of 21 CFR 820 Part 11 is required.
  • Knowledge of FDA QMS requirements, ISO-13485, European Medical Device Regulations and Canadian Medical Devices Regulations.
  • Experience with HW and SW interfaces, as well as the HW and SW architecture is required.
  • Design transfer and production ramp-up experience is desirable.
  • Experience with using lifecycle management tools for requirement management and traceability (e.g. JAMA) is required.
  • Experience using change control management tools to problem resolution activities desired.
  • Experience with system testing processes and tools is preferred.
  • Experience with usability testing processes and tools is preferred.
  • Experience in applying Agile principles to developing medical devices including HW engineering is preferred.
  • Willingness and ability to travel domestically and internationally up to 20% of the time.

 

About Bio-Rad:

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.

 

EEO/AA Employer/Veterans/Disabled/Race/Ethnicity/Gender/Age

 

Agency Non-Solicitation: 

Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

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