Verification & Validation (V&V) Manager

📍 Location: Caesarea, Israel

🕒 Employment Type: Full-Time

🏥 Industry: Medical Device

Position Summary

This is an exciting opportunity to shape and lead V&V strategy across groundbreaking medical technologies that make a real clinical impact. If you’re passionate about quality, thrive in a multidisciplinary environment, and want to influence how innovation turns into life-changing medical solutions — we’re looking for you.

Key Responsibilities

• Manage and mentor a growing V&V team, fostering a culture of quality, accountability, and continuous improvement.
• Define and lead the V&V strategy, master plans, and schedules aligned to product development cycles and regulatory requirements. Coordinate V&V activities with external testing laboratories and vendors to ensure high-quality and timely deliverables.
• Champion continuous improvement of V&V tools, methodologies, and infrastructure
• Oversee and execute verification and validation activities, including protocol design, testing, and documentation for capital systems and disposable devices.
• Ensure robust test method development, validation, and equipment qualification in accordance with industry and regulatory standards.
• Drive readiness for regulatory submissions and audits through comprehensive V&V documentation and compliance.
• Partner closely with R&D, Quality Assurance, Regulatory Affairs, Clinical, and Manufacturing teams to ensure integrated and risk-based V&V planning.
• Actively participate in design reviews, risk assessments (per ISO 14971), and contribute to the development and maintenance of DHF and DMR.
• Ensure all V&V activities comply with applicable regulatory standards, including FDA, ISO 13485, ISO 14971, IEC 60601, and EU MDR.

Qualifications & Experience

• Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related technical field.
• Minimum of 5 years of progressive experience in V&V within the medical device industry
• Proven experience in leadership or management roles.
• Proven ability to build and scale V&V infrastructure or teams
• Demonstrated expertise in capital equipment and disposable device testing, including system-level and component-level V&V.
• Familiarity with software validation and automated test systems.
• In-depth knowledge of design controls, risk management, and regulatory frameworks (FDA, ISO 13485, ISO 14971, IEC 60601, EU MDR).
• Proficiency in test method development, statistical analysis, and test method validation (TMV).
• Strong leadership, project management, and cross-functional collaboration skills.
• Hands-on experience with design transfer and manufacturing validation
• Excellent written and verbal communication skills in English & Hebrew.

Soft Skills

• Strong communication and presentation skills – able to clearly convey technical concepts to diverse audiences.
• Hard worker with a proactive mindset – takes ownership and drives projects to completion.
• Analytical and detail-oriented – ensures accuracy and compliance in all deliverables.
• Collaborative team player – thrives in cross-functional environments.
• Leadership and mentoring ability – inspire and develops team members.
• Adaptability and problem-solving skills – handle challenges with creativity and resilience.
• Time management and organizational excellence – prioritizes effectively under tight deadlines.