V&V Manager
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