What are the responsibilities and job description for the Hardware Verification &Validation Engineer (Electrical) position at Intellectt Inc?
Responsibility :
- Writing detailed Product verification test plans, test protocols / procedures and test reports and conducting analysis of test results
- Define, document, and continuously improve verification plans and protocols including conducting peer reviews and maintaining traceability to requirements.
- Perform system verification tests and conduct analysis of the test results to ensure complete verification of the requirements, identifying, analyzing, owning, and driving technical issues to resolution.
- Lead the development of test method validation (TMV) strategy, Plan and perform the execution of TMV such as : gage R&R, linearity and bias studies, etc.
- Medical device background preferred. Experience with the following standards is preferred, but not required : ISO 14971, IEC 60601-1, IEC 62304, IEC 60601-2-4, and / or IEC 60601-1-2.
- Designs Hardware test fixtures and other test aids needed to perform design verification test (Low / Medium Complexity)
- Creation of electrical schematics, layout, and drawings in Mentor Graphics Expedition-Compatible formats would be a plus.
- Tool Assessment / Validation per QMS Process, Medical device Verification and validation experience is required.
- Understanding of design controls used in medical device development is required.
- Experience using tools and measuring equipment (Oscilloscopes, function generator, DMM, Environmental chambers, power supply, etc.)
- Familiar with GDP skills and Proficient technical writing skills
