In this role, you will
Develop planning control of verification and validation activities, ensuring compliance with regulatory standards and company quality objectives
Hire and direct staff to meet scheduled commitments.
Evaluating and understanding our current state of testing and driving change to increase test automation and improve our overall testing practices.
Developing test strategies for test automation and manual verification and validation.
Develop the test development processes including designs, reviews, implementations, and test execution.
Continuously improving testing methodology, best practices, and standards to provide consistent testing across products.
Work closely with other teams to build and maintain testing infrastructure and tooling.
Work collaboratively with others to drive best practices and reduce the cost of V&V effort.
Periodically review how the test strategy aligns with the latest available technologies and industry trends
BSc degree in System, Mechanical, Electrical or Biomedical Engineering or related field
Proven experience in leading and conducting V&V activities of Medical devices, including writing, and executing test plans and protocols for medical devices with a strong emphasis on QA/RA and problem-solving
Experience with multi-disciplinary medical device companies.
Strong technical background, and understanding of complex systems including processes.
Formal and practical knowledge of testing methodologies including design and implementation of test protocols, test harnesses tools, infrastructures, and test automation.
Implementation of quality methodologies (Six Sigma and, DFx)
Excellent written and verbal communication skills – Demonstrated knowledge of global quality and regulatory environment for medical devices including FDA CFR 21 part 820.30 and IEC 60601-1-1 (CE mark), ISO 13485, and risk management requirements and development dependencies
Deep understanding of Automation software tools and testing, technology strategy, healthcare processes, and regulatory requirements, including FDA 510(k), EU MDR, hardware compliance, EMI/EMC, QMS, and validation protocols.
Fluency in English written and spoken.
