Senior NPI Engineer
1 week ago
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.
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