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Verification and Validation Engineer

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Location: Saint Louis, United States
Position Type: Unfixed Term
Job Function: Engineering

A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions that detect disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 5,000 team members across 12 sites or subsidiaries, including Salt Lake City based BioFire Diagnostics. We believe in the power of diagnostics and bioMérieux sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health across the globe. Come be a part of our mission to help save lives.

 

POSITION SUMMARY:

The purpose of this position is to provide support to verification activities through mentorship in the writing, execution, and summarization of verification protocols and in some cases performing this work directly 

 

PRIMARY DUTIES:

  1. Work with multidisciplinary engineering team members to design, construct, author, and execute engineering, verification, and reliability tests and protocols
  2. Collect and analyze data, and generate reports
  3. Support development of project documentation (FMEAs, specifications, plans)
  4. Participate in technical reviews
  5. Maintain configuration management documentation and support instrument prototype builds
  6. Support instrument, PCB, and firmware troubleshooting and issue resolution
  7. Maintain compliance with the design control guidelines and Quality requirements within the company’s regulated ISO\ FDA environment

 

Education and Experience:

  1. Bachelor’s Degree in Engineering with 5+ years of engineering/V&V experience or Master’s Degree in Engineering with 3+ years of engineering experience.  Medical Device field is preferred. 

  2. 10+ years of releveant experience performing engineering functions will be considered in lieu of degree.

 

Knowledge, Skills and Abilities: 

  1. Knowledge of electro/mechanical production processes.
  2. Technical skills in the relevant Manufacturing Engineering disciplines.
  3. Knowledge of FDA, QSR and ISO quality systems.
  4. Well-grounded in fundamental engineering design principles and test methods with demonstrated hands-on design competency working with complex medical instrumentation.  
  5. Experience with complex laboratory or engineering test equipment, data acquisition systems, engineering design documentation, and calibration procedures.
  6. Strong technical writing and communication skills.
  7. Exceptional attention to detail.

Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture. Our Group offers numerous possibilities: so come and join the 13,000 bioMérieux team members who already identify with these values!

 

bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.

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