Verification & Validation Mechanical Engineer

Job Description & Skill Requirement:

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

The expected salary range for this position is between $63,000 to $1,20,000 annually. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in role, base salary of internal peers, prior performance, business line, and geographic/office location.