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AlignTech Senior Manager Validation & Verification 
Israel, Center District, Petah Tikva 
825779923

08.09.2024

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.