Position Details
Verification And Validation Engineer Mechanical Apply
We have an immediate opportunity. Please find the below job description and if you are interested, please forward your resume to or call me on 732-797-9238.
Role: V&V Engineer - Mechanical
Location: Bothell, WA (Onsite)
Location: Bothell, WA (Onsite)
Job Description:
Test protocol development, Execution & Reporting:
- 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.
Test Fixture Development:
- Designs Hardware test fixtures and other test aids needed to perform design verification test (Low/Medium Complexity)
- Creation of mechanical modeling, assemblies, and drawings in SolidWorks-compatible formats.
- Tool Assessment/Validation per QMS Process
Required Skills:
- 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 (Force gauge, calipers, Instron, Vibration table, etc.)
- Familiar with GDP skills and Proficient technical writing skills
- Ability to work autonomously and with minimal supervision
