V&V Manager

Reposted 9 Days Ago
Be an Early Applicant
Caesarea, Kayseri, TUR
Hybrid
Senior level
Healthtech
The Role
Build and lead a V&V team to define methodologies and execute end-to-end verification and validation for multidisciplinary medical devices (laser, RF, ultrasound). Author test strategies, ensure regulatory compliance (FDA/CE/ISO13485), collaborate cross-functionally, drive automation and continuous improvement, support product lifecycle and manufacturing validation, and manage external certified test houses.
Summary Generated by Built In
Description

Alma, a Sisram Medical company, is a global leader in medical-aesthetic technologies, with over 25 years of experience in energy-based devices (EBD). Over the years, Alma has evolved into an integrated aesthetic and wellness ecosystem that combines medical devices, injectables, diagnostics, and personalized skincare. The company operates in a dynamic, innovation-driven environment, merging advanced technology with deep clinical understanding to create holistic solutions for aesthetic clinics. Alma’s headquarters are in Caesarea, Israel, with business operations in more than 100 countries worldwide.

  • Establish, build, and lead the V&V team from the ground up, including defining methodologies, processes, and best practices
  • Manage and mentor a small and growing team of V&V engineers
  • Lead end to end, comprehensive verification and validation activities for multidisciplinary medical devices, combining technologies such as laser, RF, ultrasound, and physics-based systems
  •  Define, author, and execute rigorous test strategies, validation plans, and protocols for complex systems
  • Ensure full compliance with medical device regulatory standards, including documentation, traceability, and validation processes
  • Partner closely with matrixed cross-functional teams including Mechanics, Hardware, Software, System Engineering, Regulatory, Clinical and Quality
  • Drive continuous improvement of test methodologies, modern tools, and automation capabilities
  • Support end-to-end product lifecycle activities including design verification, system validation, and post-market activities.
  • Partner with Operations and NPI (New Product Introduction) groups to ensure seamless transfer from design verification to manufacturing line validation
  • Manage relationships and scheduling with External Certified Test Houses for safety, EMC, and environmental compliance testing
Requirements
  • B.Sc. in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Physics, or a related exact science discipline – Mandatory
  • At least 5 years of hands-on experience leading V&V / QA, testing complex multidisciplinary systems – mandatory
  • Proven experience working in medical device companies – mandatory
  • Direct experience with systems integrating multiple technologies (e.g., laser, RF, ultrasound, or similar physical technologies)
  • Previous experience as a lead / senior role or strong potential for leadership – must
  • Prior experience in building or scaling testing activities / teams – strong advantage
  • Strong understanding of V&V processes within regulated environments (FDA, CE, ISO13485, etc.) - mandatory
  • Deep familiarity with medical device safety and software standards, specifically IEC 60601 (Medical electrical equipment safety) and IEC 62304 (Medical device software lifecycle) – Highly Preferred
  •  Hands-on experience implementing or working with Application Lifecycle Management (ALM) platforms, defect tracking tools (e.g., Jira), and test automation frameworks or data analysis tools (e.g., MATLAB, Python) – Strong Advantag
  •  Strong leadership capabilities with the ability to build a team and drive it forward
  • Deep, fundamental understanding of system-level methodologies for complex, multi-tiered / multidisciplinary products
  • Hands-on, proactive, agile approach with the ability to operate in a rapidly growing, evolving development environment
  • Strong cross-functional communication and stakeholder management skills to bridge design, quality and regulatory groups
  • High level of personal ownership, structure organizational skills, and uncompromising attention to detail
  • Ability to balance strategic thinking with hands-on execution

Skills Required

  • B.Sc. in Biomedical, Electrical, Mechanical Engineering, Physics, or related exact science discipline
  • At least 5 years hands-on experience leading V&V/QA and testing complex multidisciplinary systems
  • Proven experience working in medical device companies
  • Direct experience with systems integrating multiple technologies (e.g., laser, RF, ultrasound)
  • Previous experience as a lead or senior role, or strong leadership potential
  • Prior experience building or scaling testing activities/teams
  • Strong understanding of V&V processes within regulated environments (FDA, CE, ISO13485)
  • Familiarity with IEC 60601 and IEC 62304 standards
  • Hands-on experience with ALM platforms, defect tracking tools (e.g., Jira), test automation frameworks, or data analysis tools (MATLAB, Python)
  • Strong leadership capabilities with ability to build and drive a team
  • Deep understanding of system-level methodologies for complex, multi-tiered products
  • Hands-on, proactive, agile approach and ability to operate in a fast-evolving development environment
  • Strong cross-functional communication and stakeholder management skills
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The Company
HQ: Tel Aviv-Yafo
621 Employees
Year Founded: 1999

What We Do

You already know we create amazing technology that helps millions around the world to live better, more confident lives. You also know that we are at the top of the medical aesthetic market. But we’re here to tell you we are way more than that. We realized that in the modern life, a better way to make innovative technology, is understanding what our partners and their patients really want. To put people and their needs first. So we became better at listening and translating the true needs of your patients into outstanding and cutting-edge technology. We are transforming together. With you. This is what we been doing for the last 20 years. This is what got us to be a leading player in the medical aesthetics field. We take pride being number 1 in China and number 3 globally, and we owe this accomplishment to our people, our partners and our daring spirit. We infuse this spirit in everything we do and we invite you to join us. Whatever comes next we are there. Alma Lasers is a global innovator of laser, light-based, radiofrequency and ultrasound solutions for the aesthetic and surgical markets. Alma Lasers has been at the forefront of multi-technology systems, revolutionizing existing treatment methods and working to serve the varied and growing needs of both patients and practitioners around the world. With offices, R&D and manufacturing facilities on three continents and distributors around the world, Alma's mission is to provide modular, cost-effective and high-performance systems based on the very latest clinical research and cutting-edge technology. We enable practitioners to offer safe, effective and profitable aesthetic and surgical treatments to their patients, while allowing patients to benefit from the capabilities of state-of-the-art, clinically proven technologies and methods.

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