Senior Manager, Validation & Verification

Department: Research & Development

Location: EMEA-Israel

Description

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)
• 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.
  
  

Applicant Privacy Policies

Review our Applicant Privacy Policies for additional information.

Global Diversity Statement

At Align, we believe in the power of a smile, and we know that every smile is as unique as our employees. As we grow, we are committed to building a workforce rich in diverse cultural backgrounds and life experiences, fostering a culture of open-mindedness and compassion. We live our company values by promoting healthy people and healthy communities, all with the intent of changing millions of lives, one unique smile at a time.

Equal Opportunity Statement

Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.