Verification and Validation (V&V) Team Leader

Who are we?

We are here to improve the lives of patients through innovative technologies. As an interdisciplinary team of professionals, we are passionate about developing game-changing solutions that have a real impact on global health.

We apply machine learning to translate the complex signaling of the immune system into simple, actionable diagnostic insights. MeMed’s machine learning-based diagnostics address key clinical and medical challenges in infectious diseases and inflammatory disorders (www.me-med.com)

Who are we looking for?

If you're a highly motivated, top-notch professional and a true team player, with a passion for bringing game-changing medical products to life and making a real impact on patients' lives, we would love to hear from you!

We are seeking a highly talented and motivated individual to join our team as a Verification and Validation (V&V) Team Lead. The ideal candidate has strong experimental skills, excellent interpersonal abilities, and a passion for working in a dynamic, fast-paced, and highly demanding startup environment. A strong spirit of self-learning and the ability to explore new technological domains, including AI applications in in-vitro diagnostics, are highly valued.

Responsibilities

• Hands-on approach in the planning, execution, and documentation V&V activities for in-vitro diagnostic medical devices, ensuring compliance with ISO 13485, FDA, IVDR, and other regulatory requirements.
• Actively perform and oversee testing, including software and system verification.
• Develop and implement V&V strategies, including test plans, protocols, and reports for design verification and design validation.
• Support running design integration studies together with system and assay development teams
• Drive defect tracking and resolution, ensuring issues are documented, prioritized, and addressed effectively in collaboration with other relevant teams in MeMed.
• Support the validation of testing tools, ensuring they are qualified, calibrated, and compliant with relevant regulatory standards
• Manage test execution, data analysis, and troubleshooting to ensure the reliability, safety, and performance of medical devices.
• Drive continuous improvement by optimizing V&V methodologies, automation, and documentation practices.
• Support regulatory submissions by providing V&V documentation and justifications.
• Provide technical support during internal and external audits, ensuring V&V documentation aligns with regulatory expectations.
• Review requirements, specifications and technical design documentation to provide meaningful feedback
• Participate in design reviews, risk assessments, and failure investigations.
• Lead and mentor a V&V team, fostering a culture of technical excellence, collaboration and transparency.
• Thrive in a fast-paced startup environment, demonstrating adaptability and problem-solving skills.
• Report to the Head of R&D
• Position based in Haifa.

Required skills

• 5+ years of experience in V&V in the medical device industry.
• 2+ years of experience in leading a team of V&V engineers
• Academic degree in Engineering or Life sciences
• In-depth knowledge of design control processes, SW development cycles and applicable medical device regulations and standards
• Hands-on experience in system and SW testing.
• Ability to prioritize tasks, manage multiple projects, and work in a fast-paced startup environment.
• Highly self-motivated – a problem solver that “makes it happen”
• Excellent communication skills working with multidisciplinary teams
• Fluent in English

Advantages

• Previous experience in running V&V for in-vitro diagnostic devices
• Experience with testing cloud-based systems
• Experience with testing AI-integrating systems