Description
We are looking for an experienced Design Assurance professional to take a central role in our QA/RA team and drive Design Controls activities across the product lifecycle. You are a structured, detail-oriented team player who thrives in a regulated environment, enjoys working closely with R&D and cross-functional teams, and is motivated to ensure high-quality, compliant, and well-documented product development.
Who we are
We are here to improve lives by restoring sight worldwide by a robotic platform for vision saving surgery. Our company will improve the way ophthalmic surgery is delivered to vision impaired individuals now and for decades to come. We are rapidly growing, funded by leading international VCs, and are looking to expand our small, motivated, multi-disciplinary and phenomenal team. Joining us 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.
Responsibilities
- 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).
Skills and Competencies
None
