Senior Engineer- V&V

Responsibilities: <ul><li>Lead/Execute, perform, summarize, and report out System verification test activities Medical devices: Which includes but not limited to:</li><li>Understand URS (User requirements) / System Requirements and prepare the System Level Test cases and Prepare test procedures.</li><li>Understand the product functionality and perform the Functional and Performance testing for the product.</li><li>Lead/Support and perform Design Verification activites</li><li>Drive/Perform Installation/Operational/Performance Qualification Protocols</li><li>Prepare Traceability Matrices and Final Reports.</li><li>Lead compliance/ closure of Regulatory and Quality requirements</li><li>Develop Test instructions and Test protocols.</li><li>Follow instructions clearly from Design engineers during Test execution.</li><li>Support Design engineers in Test fixture creation, building up &amp; tearing down Test equipment.</li><li>Plan Lab logistics and maintain the material supply for testing requirements.</li><li>Diagnose, isolate and investigate problem reports and defects.</li><li>Support to work with external test houses (such as EMI, EMC tests for electrical boards and full device) to define the test scope, author the test plans, test procedures, execute &amp; consolidate the reports.</li><li>Ensure good documentation and Good Manufacturing practices are followed in the Verification Process.</li><li>Experience in IEC basic safety, EMI-EMC standards</li><li>Interacts with design team to resolve tests-related technical issues.</li><li>Presents the findings / objective evidences and able to present with rationale with applicability / exclusions</li><li>Identify and report any quality or compliance concerns and take immediate corrective / Preventive action as needed.</li></ul>&nbsp;Requirements: <ul><li>Bachelors Degree in Mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field</li><li>Overall 6 to 10 yrs of experience with minimum 3 years in System Verification testing and performance testing.</li><li>Hands on experience in overall final design verification/validation(V&amp;V) testing of medical products.</li><li>Relevant technical testing/reliability experience in electro-mechanical, electrical testing of Medical Devices.</li><li>An understanding of test methods and processes as well as the methods used to verify product in the realms of; mechanical, electrical, functional testing environments.</li><li>Basic hands on experience in data analysis of Performance testing and Sample size calculations for variable/Attribute data</li><li>Experience in Tools like Minitab( Data Analysis) / JIRA ( Defect ) / ALM ( test Environment) etc.</li><li>Understanding of hardware and software product design methodologies and test practices.</li><li>Experience in medical device or similar product development, design verification/validation, system integration (hardware/Subsystem/Software), risk management, reliability engineering, process validation and Quality systems</li><li>Basic understanding of and adherence to FDA,MDD/MDR, ISO and IEC design control procedures, regulations and standards.</li><li>Self-motivated with good interpersonal skills.</li><li>Ability to follow instructions clearly.</li></ul>&nbsp;Preferred Candidates <ul><li>System V&amp;V Engineers with Experience in Infusion pumps design verification testing.</li></ul>&nbsp;

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Senior Engineer- V&V

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Senior Engineer- V&V

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