V&V/Manfacturing Engineer

Manufacturing/V&V Engineer – Surgical Lasers (Medical Device)

neoLaser designs, manufactures, and sells top-notch quality medical laser products with superb performance and affordability. The company holds certifications and clearances enabling sales of its high-end medical laser systems in over 40 countries. Our flagship product, the neoV laser, offers state-of-the-art options for Endovascular and Proctology treatments, including unique surgical probes.

We are seeking a Manufacturing/V&V Engineer to join our team. In this role, you will provide engineering support for ongoing manufacturing including design transfer, process validation, and scale-up of potential new products/changes into compliant manufacturing while also assisting early-stage design and prototyping.

Key Responsibilities

·      Lead obsolescence activities as needed to ensure ongoing supply and manufacturing, including leading ECOs and validations accordingly

·      Be responsible for ongoing configuration management (drawings, board versions etc). Support ECOs &/ design modifications, and continuous product improvements

·      Analyze system-level issues from complaints and NCMRs and propose design improvements across optics, mechanics, electronics, and software to reduce failure rates

·      Drive DFM/DFA/DFT activities and influence design to ensure manufacturability, reliability, and cost-effectiveness, including optimization of manufacturing processes, fixtures, and validations (IQ/OQ/PQ)

·      Support new product introduction (NPI) and transition from prototype to volume production

·      Ensure compliance with ISO 13485, FDA QSR, IEC 62304 and IEC 60825 laser safety standards

·      Support and assist R&D on design feasibility, prototyping, and testing of new capabilities including V&V testing

Qualifications

·      B.Sc. in Mechanical Engineering

· years' experience in NPI/Process/Manufacturing Engineering of surgical medical devices

·      Hands-on experience with similar and relevant manufacturing processes.

·      Familiarity with QA/RA processes, design controls, ISO13485 and risk management (ISO

·      Proficiency in SolidWorks and strong problem-solving skills.

·      Excellent English communication skills.

Location:
Caesarea, Israel, full time position on site

Please send relevant application to: -