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Verification and Validation Engineer - Hazelwood Missouri
Company: bioMerieux Inc. Location: Hazelwood, Missouri
Posted On: 05/03/2024
Verification and Validation Engineer Location: Hazelwood, MO, United States Position Type: Unfixed Term Job Function: Engineering Share: share to e-mail A family-owned company, bioMerieux 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 company's regulated ISO\ FDA environment.Education, Training, and Experience B.S. in an Engineering discipline with 5+ years of engineering experience or M.S. in an Engineering discipline with 3+ years of engineering experience. Medical Device field is a plus. Other Skills and Abilities
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