Senior NPI Engineer

Senior NPI in the 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 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.
• Designed and implemented production tools, defining operational processes and ensuring seamless integration into manufacturing environments

Requirements

• BSc. in Mechanical Engineering.
• 5+ years of experience in design engineering & manufacturing environments of multi-disciplinary products.
• A team player with a strong willingness to learn new technologies and dedicate time and effort to a challenging and demanding technological environment.
• Understanding and knowledge of relevant regulations and standards FDA QSR, ISO 13485, ISO 14971, MDD.
• Managed the full lifecycle of production equipment and jigs, from writing specifications and mechanical design to testing, validation (IQ, OQ, PQ), and ongoing support.
• Designed complex mechanical assemblies and system integrations using SolidWorks, from conceptual design to detailed production drawings.
• Provided hands-on troubleshooting for production challenges, with a focus on cleanroom environments and specialized manufacturing equipment
• Worked extensively with manufacturing technologies including CNC machining, sheet metal forming, Mold design, and Familiarity with 3D printing systems for prototyping and development, PCBA’s - an advantage.
• Experience with process optimization/improvement, lean manufacturing, 5S, Root cause analysis & CAPA - an advantage.
• Experience with SolidWorks.