Senior V&V Engineer

2 weeks ago

Netanya Center District, Israel HumanTouch Surgical Full time $90,000 - $120,000 per year

HumanTouch Surgical (continuing Human Xtensions) is a cutting-edge start-up developing multi-disciplinary products in the field of Minimally Invasive Surgery.

We are seeking a V&V engineer to join our V&V team. It is a wonderful opportunity to be part of the robotics research and development department. You will be an integral part of all product prototyping, development, integration, bring-up, and testing. This position requires agility, an open mindset, and a diversified skillset to head many different tasks and operations.

Our offices are in Netanya. We offer a dynamic, innovative environment where you will have the opportunity to make a significant impact while working alongside sharp, professional individuals who are passionate about the future of medical technology. If you're ready for a new challenge and eager to grow, we'd love to hear from you

Responsibilities:

§ The V&V engineer role involves quality & test advocacy, promoting design for testability and resolution of issues that block the testing effort.

§ Design and write test protocols, reports and conduct formal testing to verify and validate the safety and efficacy of new and existing HumanTouch Surgical products

§ Work with cross functional teams (product managers, regulatory, system engineers, mechanical and SW)

§ Keep abreast of regulations and best practices for medical device human factors (e.g. IEC 62366, AAMI HE75, FDA Applying Human Factors and Usability Engineering to Medical Devices)

§ Documentation of the test results as raw data according to QA requirements

§ Troubleshooting in the event of abnormal testing results

§ Analyzing & summarizing test results and producing reports

Requirements:

Education & Experience:

  • Bachelor's Biomedical Engineering , Mechanical Engineering or other related degree.
  • 3+ years of experience in verification and validation (V&V) of medical devices or other regulated industries.

Technical Expertise:

  • Strong understanding of verification methodologies, including test planning, protocol development, execution, and reporting.
  • Hands-on experience with hardware, software, and system-level testing for medical devices.
  • Familiarity with mechanical, electrical, and software verification techniques, including environmental testing, reliability testing, durability and accelerated life time testing.

·      Basic knowledge in Solidworks - an advantage

Regulatory & Compliance Knowledge:

  • Experience working within a design control process (DHF, DMR, traceability matrices) to ensure regulatory compliance.
  • Understanding of Good Documentation Practices (GDP) and requirements for regulatory submissions.

Problem-Solving & Analytical Skills:

  • Strong ability to analyze test data, identify defects, and work with cross-functional teams to resolve issues.

Collaboration & Communication:

  • Ability to work in cross-functional teams, including R&D, Quality, Manufacturing, and Regulatory Affairs.
  • Experience preparing technical reports, verification plans, and validation documentation for regulatory submissions.
  • Strong written and verbal communication skills, with the ability to present test results to internal teams and external regulatory bodies.

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