New Product Verification and Compliance Manager

• Lead a team of V&V engineers to support all design control and software, hardware and system
verification testing activities for medical devices.
• Participate in design reviews and requirement reviews to develop thorough test designs and test
cases for complete test coverage.
• Plan and strategize for test design and test procedures to ensure complete functional and nonfunctional test coverage for multiple projects concurrently.
• Establish V&V framework to support positive, negative and boundary testing and develop test
automation where practical.
• Develop Verification and Validation plans. Established test strategy and tactics on assigned projects
and ensure full execution of the strategy.
• Create and Execute exploratory, functional, regression, system, performance and reliability tests
according to established verification plan in test environment for SW, electrical, mechanical and
packaging (if any)
• Report defects and assist developers in reproducing defects and assist in finding the cause to
various defects. Define processes for early detection of defects within Software Development Life
Cycle (SDLC).
• Ensure the project meets the test entrance criteria before testing commence and test exit criteria
before the project release. Define key progress indicators from testing perspective and provide
regular test summary dashboard to all key stakeholders
• Create traceability matrix report between test cases, requirements and design. Provide timely
communications on significant issues or risks identified in testing and provide risk mitigation
planning where applicable.
• Create and maintain risk management files including preliminary risk analysis, failure mode effect
analysis, risk evaluation, mitigation and overall risk acceptability.
• Establish process pertaining to design controls, V&V, risk management and other associated.
 
Must Haves
• BS in Engineering with strong background in electronics and software
• 8 years of progressive V&V management responsibility with at least 4 years in the medical device
industry, or equivalent work experience and/or professional qualifications
• Working knowledge of, and auditing experience to, the FDA Quality System Regulation, ISO 13485,
IEC 62304, and the EU Medical Device Regulation.
• Experienced in product risk management to the requirements of ISO 14971.
• Skilled in statistical methods, statistical process control and sampling plans.
• Familiar with reliability analysis and test methods.
• Working knowledge of IEC 62304.