Benefits at bioMérieux:
- Low-cost medical, dental, and vision benefits starting day one
- 11 paid holidays
- 160 hours of paid time off
- Annual bonus
- 9.5% 401k company contribution with no vesting period
- Tuition reimbursement up to $10000 per calendar year
- Onsite cafeteria with daily food stipend
Position Summary:
At bioMerieux, our dedication to public health is the thread that connects everything we do. We pioneer, develop, and produce high quality in vitro diagnostic solutions that help healthcare professionals quickly and reliably determine a pathology or the source of a contamination and provide them with crucial information for optimal patient care. Be a part of the team that is responsible for deploying and sustaining the manufacturing of this life saving equipment. You will be working in a dynamic environment with a cross functional team including engineering, production, quality assurance, purchasing, supply chain logistics, and others. If you are passionate about solving real-world problems, you will find a home among our engineers, software developers, microbiologists, and numerous other professionals working to commission, qualify, and validate manufacturing support systems, along with verifying the design of the products themselves.
Primary 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:
-
Bachelor's Degree with 3+ years of Validation, Verification, and/or Equipment Qualification experience in a manufacturing environment OR Master's Degree with 2+ years of Validation, Verification, and/or Equipment Qualification experience in a manufacturing environment also accepted
- Software Validation experience is desired but not required
- Medical Device experience 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.
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