changing lives.
We are looking for a Validation & Verification Senior Manager to join our team. As part of the role, you will work closely with R&D to specify, execute, and report the required tests, as well as with QA / RA to ensure that the medical QMS complies. In this role, you will play a key role in ensuring the quality and reliability of our products through rigorous testing and validation. A strong technical background, excellent problem-solving skills, and the ability to work collaboratively with various teams are required for this role.
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
In this role, you’ll need …
- 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) - Advantage
- 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.
