Role: Validation Engineer (Medical Devices)
Location: San Diego, CA
Duration: 12+ Months
Job Description:
· Combination of Mechanical & Manufacturing, with Medical Devices background.
· Hands on experience in Method Transfer, Process Validation (IQ /OQ /PQ), Validation performance and Reports.
· Working on sample size determination, creating sample size for Testings, for Design Verification, Validation, Process Validation and Test Method Validation Hands on experience working on Validation reports for the Manufacturing site that are moving from once place to another. This includes Facility Validation as well.
· Hands on experience on drafting Protocols, Testings, Data Analysis and Test Reports
· Extensive Experience on using Minitab for Data Analysis, R&R Analysis after Test Execution
· Understanding on Software elements would be an added advantage
· Knowledge on IVDR and DHF Remediation also will be an added advantage
· Good understanding on Requirements analysis (Customer Reqs, Technical Reqs, Functional /Product Reqs), Traceability Matrix, DHF Remediation and Risk Management with FMEA working.
· Experience with QC Tools and Statistical Methods
· Understand Product BOMs and Assessment with reference to information available in PLM/Other Repository
· Working closely with customer counterparts and understanding their Requirements and working on collaborative mode. Understand the customer requirements and suggest alternative feasible concepts.
· Good knowledge in various manufacturing process like Machining, Sheet Metal, Plastics and DFM/A.
· Familiar with Engineering Change Orders and Engineering Change Notes
· Proven track record of problem solving
· Knowledge in Mechanical Design, Bill of Materials, Product Life Cycle stages
· Provide Project status updates to the work group, tracking the overall project implementation.
· Good Communication and documentation skills. Good knowledge in MS PowerPoint and Excel.