Lead NPI Engineer

Senior NPI- engineering team

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 senior mechanical engineer to join our NPI / engineering team. It is a wonderful opportunity to be part of the robotics research and development department.

The senior engineer will take a leading role in engineering activities and projects ranging from Design Transfer and cost reduction to production stability. 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

• Creating assembly and testing instructions.
• Support ongoing production processes and equipment, training of subcontractors & production line.
• Construction and management of product DMR including BOM, SOP's, mechanical & electrical specs.
• Design improvements from design freeze and during mass-production.
• Design, qualify, document, and validate assembly & test fixtures/Jigs and tools.
• Performs root causes analysis on equipment and manufacturing process issues.
• DFx methods (design for manufacturing, testing, cost optimization) design and secure supply chain -quality, schedule, cost.
• Provides technical evaluation and implementation plan input to the Corrective Action/Preventive Action (CAPA) program.
• Configuration management and Implementation of engineering changes/ECO.

Requirements

• BSc. in Mechanical Engineering.
• 5+ years of experience in design engineering & manufacturing environments of multi-disciplinary products.
• Understanding and knowledge of relevant regulations and standards FDA QSR, ISO 13485, ISO 14971, MDD.
• Experience with process validations and qualification IQ/OQ/PQ.
• Knowledge in the following manufacturing technologies: CNC, plastics injections, cable assemblies, PCBA’s - an advantage.
• Experience with process optimization/improvement, lean manufacturing, 5S, Root cause analysis & CAPA - an advantage.
• Experience with SolidWorks.