Company:
Triunity Software
Location: San Jose
Closing Date: 22/10/2024
Salary: £150 - £200 Per Annum
Hours: Full Time
Type: Permanent
Job Requirements / Description
Title: Team Lead Validation Engineer
Experience: 8 - 10 years
Location: San Jose, CA, USA
Education: Bachelor of Science in Engineering, B.E. / B.Tech. Mechanical Engg. / M.S. Mech. Engg.
Note: Candidates should have experience working in Medical Devices or with companies that manufacture Medical Devices.
Required Experience:
- 6 years relevant experience in medical device manufacturing.
- Clean room environment experience.
- Experience with Test Method Validation and/or Measurement System Analysis is preferred.
- Knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred), is a plus.
- Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485.
- Strong organizational skills, detail-oriented.
- Ability to collaborate within an organization across all functional departments (e.g. Legal, Regulatory, Operations, Procurement, Clinical Affairs, Marketing, Quality, etc.).
- Ability to work to a deadline and handle multiple tasks simultaneously.
- Experience with Microsoft Office including Word, Excel, PowerPoint.
- Experience with 3D CAD Software SolidWorks.
- Experience working with Engineering change management software & releasing engineering change orders.
Job Duties:
- Process and equipment qualification (IQ/OQ/PQ).
- Development of test methods for Design V&V, Process Validation, and Production.
- Validation of test methods.
- Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work.
- Authoring/releasing of new test methods and editing/redlining of old test methods.
- Experience working in a regulated and/or medical device environment.
- Define equipment requirements.
- Draft equipment specifications.
- Work on change management and releasing engineering change orders.
- Design process validations and identify critical process parameters related to equipment.
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