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Senior Systems V&V Engineer

Senior Systems V&V Engineer

  • 2022-28933
  • Pleasanton, California, United States
  • Boulder, Colorado, United States

Bio-Rad is looking for an enthusiastic Systems Engineer to join the fast-growing Digital Biology Group of Bio-Rad based in Pleasanton, CA. The Digital Biology Group is a multidisciplinary team focused on developing innovative products using our core partitioning technology. Our ddPCR and ddSeq systems have enabled scientists around the world to make impactful discoveries in the life sciences and healthcare. Our mission is to continue creating and providing new tools to scientists that will facilitate more discoveries and advances in research.

 

Within this organization we have an immediate need for a Senior Systems Verification and Validation Engineer to fill a key position focused on the verification and validation of cutting-edge droplet digital PCR systems. You will report directly to the Head of Systems Integration and Verification and be part of a larger multi-disciplinary R&D team.  Come join us and be a key player in our next innovative instrument. The work will span from the research stage through product launch. At our DGB R&D center, you can have big company impact while working at a small, nimble and dynamic site. The role can also be based out of our Ann Arbor, MI or Boulder, CO R&D sites.

Responsibilities

  • Applies system engineering principles to develop cost-effective, reliable, high-quality systems that satisfy customer needs and drive business strategies.
  • Establish master design verification & validation plan for a product in development.
  • Review requirements from a verifiability/testability standpoint.
  • Lead verification personnel in the development of verification protocols against product requirements and coordinate cross functional reviews on protocols prior to execution.
  • Lead validation personnel in the development of validation protocols against customer requirements and coordinate cross functional reviews on protocols prior to execution.
  • Leverage system architecture to avoid duplication of effort between system and subsystems and impact analysis to manage regressions.
  • Author design verification and validation reports.
  • Design, create test fixtures and author assembly, operating instructions for test fixtures.
  • Coordinate development of test tools to simulate errors/faults and acquire objective outputs.
  • Ensure trace matrices from requirements to specifications to verification to validation are complete.
  • Support failure analysis efforts through basic experiment planning, execution, documentation, and reporting.
  • Work closely with Systems Engineers, Instrument Engineers, Assay Developers and Software Developers in all aspects of product development.
  • Communicate results effectively, guiding the team through data and observations on critical design decisions.
  • Champion and mature the system design verification and validation process.

Qualifications

  • Bachelor’s degree or equivalent in a related engineering discipline.
  • 5+ years of commercial experience developing and Sustaining Platforms for Analytical Applications is Required.
  • Extensive Hands-on Experience with Pumps, Valves, Sensors, Feedback controls, and Firmware for Microfluidic Applications is Required.
  • Leverages strong communication and interpersonal skills to drive and implement decisions.

Preferred Qualifications:

  • PhD in Electrical/Mechanical/Chemical Engineering or Equivalent is desirable.
  • Experience with Systems Architecture Design, Technology Development, and Systems Integration with Microfluidic or Flow-cytometry Instruments is Highly Desirable.
  • Demonstrated skill in applying Risk Management, Usability and Reliability tools and practices, expertise, and methodologies to deliver complex programs.
  • Knowledgeable in ISO 13485 Medical Device Quality Management System Requirements.
  • Knowledgeable in ISO 14971.
  • Knowledge of manufacturing and process development activities such as qualification, validation, design of experiments (DOE), and FMEA.
  • Working Knowledge of Statistics, DOE, DFSS, and/or Signal Processing Algorithm Optimization is Desirable.
  • General Knowledge or Experience with Molecular Biology, Immunology, or Biological Sciences is Desirable.

 

Vaccination Requirement:

 

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.

 

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.

 

#L1-PB1

 

 

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