Urgent hiring || Validation Engineer- Medical Device || Location: Carlsbad, CA || Employment: Full Time Hi, Hope you are keeping yourself well and w
Urgent hiring || Validation Engineer- Medical Device || Location: Carlsbad, CA || Employment: Full Time | Hi,
Hope you are keeping yourself well and we wish you to do great, we have matching job for you , please have a look once and let us know your interest. Title: Validation Engineer- Medical Device
Location: Carlsbad, CA
Employment: Full Time Desired Skills and Experience:
• Combination of Mechanical & Manufacturing, with Medical Devices background.
• Hands on experience in Method Transfer, Process Validation (IQ /OQ /PQ), Validation performance and Reports.
• Hands on experience working on Validation reports for the Manufacturing site that are moving from one 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
• Working on sample size determination, creating sample size for Testings, for Design Verification, Validation, Process Validation and Test Method Validation
• 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 | Thanks & Regards
Parth Pradhan
Technical Recruiter
Email: parth.p@emonics.com
Phone: (201) 977- 5082
www.emonics.com
1260 Centennial Ave, Suite 1A, Piscataway, NJ- 08854 | | | |
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