
Manufacturing Engineer
1 week ago
neoLaser
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: -
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