Design Assurance

Who we are

Our goal at ForSight Robotics is to restore eyesight worldwide by pioneering a first-of-a-kind robotic platform for vision saving surgery. Founded by medical robotics leaders, we combine state-of-the-art robotic microsurgery, advanced visualization, and data analytics. Our robotic system is designed to solve the enormous limitations of current ophthalmic surgery - scale, accuracy, and reproducibility, thus giving surgeons a game-changing technology to tackle the huge problem of preventable blindness and visual impairment.

We are rapidly growing, funded by leading international VCs, and are looking to expand our small, motivated, multi-disciplinary and phenomenal team of robotic engineers, software developers, clinicians, and world-class advisors. This is an opportunity to work towards saving vision across the globe, collaborating with others to realize a dream, and tackle an enormous challenge that will help drive your career forward. We’re building a company to improve the way ophthalmic surgery is delivered to vision impaired individuals now and for decades to come.

Who we are looking for

We are looking for an enthusiastic and passionate Design Assurance to take a central role in our QA/RA team and support Design Controls activities.

As part of your role, you will:

• Ensure the product is developed per a well-defined Design Controls process and procedure, from planning, to design and implementation, and finally to verification and validation, during which everything is documented, risks mitigated, and traceability visible end-to-end
• Support product development at all project phases, ensure development and design reviews (development gates, PDRs, CDRs etc.) are aligned with the product development plan and with the applicable procedures and processes, and follow up on action items from design reviews
• Support requirements initiation / rationales for requirements and testing (e.g., testing covers all requirements, sample sizes etc.)
• Manage DHF activities and documentation, initiate, and review project deliverables and ensure that the deliverables are in compliance with company’s QMS, applicable standards and regulations
• Handle and coordinate Risk Management activities (including sound experience with ISO 14971)
• Take a leading role in external audits and regulatory filings

Requirements

• B.Sc in Mechanical / Biomedical / or similar from a known academic institution.
• 5+ years of hands-on experience in a similar role in a multi-disciplinary medical device company (Hardware, Software, Mechanics), working according to the MDR and CFR 21 Part 820, ISO 13485 regulatory requirements, ISO 14971, IEC 62304, IEC 60601
• R&D experience in a multi-disciplinary company – advantage
• Demonstrate in depth experience and understanding of product development lifecycle and design control activities (including Risk Management, design input/output, verification and validation etc.) in a medical device environment
• Experience with cross functional project teamwork and collaboration with R&D, RA, QA, Product, Program, and Operations team members
• Strong interpersonal, written, and verbal communication skills (Hebrew & English)