| V&V Failure Analysis Engineer || Austin Texas || Onsite || at Austin, Texas, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=591493&uid= From: rajeev kumar, veridianta [email protected] Reply to: [email protected] HI Role: V&V Failure Analysis Engineer Location: Austin Texas (Onsite) Exp Company in the Medical device field and leader in the orthopedics market. Roles and Responsibilities Review specifications and technical design documents to provide timely and meaningful feedback for Engineering Verification & Validation activities. Ownership & Maintain the company Verification, Validation & Process Validation infrastructure (SOP, Forms, SW tools, Jigs, Simulators). Create detailed, comprehensive and well-structured V&V test protocols and reports, with the ability to maintain and cross-reference it with Risk Analysis Matrix & Design Control documentation. Define & Execute the Usability & Ergonomic Verification Test protocols. Develop, apply & maintain test methods, equipment and instruments for the medical device throughout all development and production stages of the product to meet user needs & product requirements. Being involved in the reliability and integration tests for prototypes and products. Developed manufacturing process validation activities for sustain & NPI projects (IQ\\OQ\\PQ, Validation Plans, Sample size, ATP, Testing forms and Documentation). Maintain relevant chapters of DHF & DMR. Development and implementation of methodologies for collecting and analyzing field failure data and determining root cause of field failures (FTA, LOGs investigation, SPR, service Failure analysis, etc). Leading company efforts to eliminate life field failures in products. Coordinating failure analysis with other disciplines as necessary to lead to determination of root cause. Ensuring corrective actions are implemented in manufacturing to prevent recurrence of failure. Incorporating automation and improvement of failure analysis process. Position Requirements: BA/BSc. Degree in Mechanical \\ Biomedical or equivalent practical experience. 1-2 Years of proven Verification & Process Validation experience in medical device industry with a strong emphasis on problem solving, along with written and verbal skills. Root cause analysis methodologies and six-sigma methodologies Optional. Knowledge and experience with Medical Device Quality Systems, ISO 13485, FDA. Knowledge and experience with environment, safety, bio-compatibility, sterility and essential performance tests (IEC 60601, EN 61508, ISO 10993-5, ISO 11135, etc.). LabView & MATLAB Experience. Full proficiency in MS-OFFICE. Strong technical orientation for understanding multi-disciplined systems. Good documentation skills and ability to communicate effectively at all levels of the organization. Can conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities. Ability to effectively prioritize and execute tasks in a high-pressure environment. Multi-tasker, independent, punctual and accurate with excellent organizational skills, Team oriented, collaborative, good personal relationships. Excellent skills in English language are required (verbal and written communication). Regards Rajeev Kumar Technical Recruiter Veridian Tech Solutions, Inc Certified by WOSB, WBENC, HUB +1 (832) 906-4045 [email protected] www.veridiants.com 11931 Wick Chester Lane Suite 150 Houston, TX, 77043 Keywords: business analyst information technology microsoft Texas http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=591493&uid= |
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| 07:24 PM 31-Aug-23 |