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Verification and Validation Engineer

Location: Hazelwood, MO, United States
Position Type: Unfixed Term
Job Function: Engineering

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

Description

Position Summary:

Develop, support, and implement verification and validation activities through mentorship in the writing, execution, and summarization of verification and validation plans and protocols. The emphasis of this position is on engineering test and support for complex medical instruments in a manufacturing environment. Develop and execute design verification and equipment, process, and non-product software validation protocols.

Essential Job Duties and Responsibilities

  • Lead verification and validation projects with minimal oversight (deliverables, timelines, materials, etc.) to support site and department initiatives.
  • Work with multidisciplinary engineering team members to design, construct, author, and execute engineering, verification, and reliability tests and protocols.
  • Write and execute protocols and test cases for verifications and validations.
  • Assure validation documentation is generated, reviewed and approved in accordance to procedures.
  • Collect and analyze data and generate reports.
  • Support development of project documentation (FMEAs, specifications, plans).
  • Participate in technical reviews.
  • Support change control processes through assessment of system changes and identifying the extent of qualification or re-qualification activities as needed.
  • Maintain configuration management documentation and support instrument prototype builds.
  • Support instrument, PCB, and firmware troubleshooting and issue resolution.
  • Continuously improve and update the validation program.
  • Comply with the design control guidelines and Quality requirements within the companys regulated ISO\ FDA environment.

Education, Training, and Experience

B.S. in an Engineering discipline with 5+ years of engineering experience orM.S. in an Engineering discipline with 3+ years of engineering experience. Medical Device field is a plus.

Other Skills and Abilities

  • Well-grounded in fundamental engineering design principles and test methods with demonstrated hands-on design competency working with complex medical instrumentation.
  • Experience with complex laboratory or engineering test equipment, data acquisition systems, engineering design documentation, and calibration procedures.
  • Experience with engineering design documentation such as drawings and schematics.
  • Strong troubleshooting skills.
  • Systems Engineering and integration skills with demonstrated relevant experience over the full product development cycle for a complex electromechanical system.
  • Must be able to work independently, manage time to work on several simultaneous projects, participate on risk assessment teams, and learn/apply new verification and validation methodologies.
  • Knowledge of electro/mechanical production processes.
  • Technical skills in the relevant Manufacturing Engineering disciplines.
  • Knowledge of FDA, QSR and ISO quality systems.
  • Strong collaborative and communication skills.
  • Exceptional attention to detail.

#LI-JS1

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [email protected].

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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