Senior Manager, Validation & Verification
IL-Petach Tikva
EMEA | English
Req #: 40810
Type: Regular Full-Time
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Overview: Join a team that is changing millions of lives. Transforming smiles, changing lives. At Align Technology, we believe a great smile can transform a person's life, so we create technology that gives people the confidence to take on whatever's next. We revolutionized the orthodontic industry with the introduction of the Invisalign system, and we have never lost sight of that spirit of innovation. Our diverse and collaborative teams are constantly pushing the boundaries of what's possible. Ready to join us? About this opportunity 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. Sound like a good fit? Great! Click the "Apply" link to let us know you are interested. Not the right fit? Don't worry, Align is quickly growing so we are creating more opportunities to expand our Align family. Please consider joining our Talent Network to receive notifications about future jobs or sharing this opportunity with others in your network. About Align Align Technology is a publicly traded medical device company that is transforming smiles and changing lives. Our global team of talented employees develop innovative technology, tools and treatment options to help dental professionals worldwide achieve the clinical results they expect. Our digital ecosystem combines the power of technology to create beautiful smiles through the integration of AI and machine learning, digital imaging and visualization, biomechanics and material science to develop the Invisalign system, the most advanced clear aligner system in the world; iTero Intraoral Scanners and OrthoCAD digital services. Did you know? Align is the world's largest manufacturer of custom 3D-printed materials. By joining Align, you will be part of a global, fast-growing company in one of the most dynamic industries. Great people, innovative technologies, and meaningful work - these are just some of the things employees say make Align Technology a great place to work. We respect your privacy. Please 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 will continue building a workforce of diverse cultural backgrounds and life experiences and fostering a culture of open-mindedness and compassion for all our employees. 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 It is our policy to provide equal employment opportunity in all of our employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Align must be legally authorized to work in the country which they are applying for and verification of employment eligibility will be required as a condition of hire. Responsibilities: ABC Responsibilities Qualifications: ABC Quals
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