What are the responsibilities and job description for the Lead Validation Engineer position at AddSource?
Job Title: Lead Validation Engineer
Experience: 8 - 10 years
Location: San Jose, CA, USA
Education: Bachelor of Science in Engineering, B.E. / B.Tech. Mechanical Engineering, M.S. Mechanical Engineering
Experience Requirements
Experience: 8 - 10 years
Location: San Jose, CA, USA
Education: Bachelor of Science in Engineering, B.E. / B.Tech. Mechanical Engineering, M.S. Mechanical Engineering
Experience Requirements
- Minimum 6 years of relevant experience in medical device manufacturing.
- Experience working in a clean room environment.
- Experience with Test Method Validation and/or Measurement System Analysis is preferred.
- Knowledge of computer software for data analysis, 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 and detail-oriented.
- Ability to collaborate within an organization across all functional departments (e.g., Legal, Regulatory, Operations, Procurement, Clinical Affairs, Operations, Marketing, Quality, etc.).
- Ability to work to a deadline and handle multiple tasks simultaneously.
- Proficiency in Microsoft Office, including Microsoft Word, Excel, and PowerPoint.
- Experience with 3D CAD Software SolidWorks.
- Experience working with Engineering change management software and releasing engineering change orders.
- Process and equipment qualification (IQ/OQ/PQ).
- Development of test methods for Design Verification & Validation (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 new test methods and editing/redlining old test methods.
- Experience working in a regulated and/or medical device environment.
- Defining equipment requirements.
- Drafting equipment specifications.
- Working on change management and releasing engineering change orders.
- Designing process validations and identifying critical process parameters related to equipment.
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