Human Xtensions is an Israeli public company developing technology in the field of Minimally Invasive Surgery. We’re looking for an experienced Mechanical Engineer to join our core engineering team.
The engineering team is responsible for all the new product design transfers, improving the production line yield, and escorting all product life cycles.
As a mechanical engineer, you will be in charge of all the production process validation activities, testing methods assessment, and continuous improvement of all the clean room jigs and tools. Also, you will actively participate in the design and development process from the engineering and manufacturing aspect.
- Developing manufacturing process tools for new products and design improvement during mass production.
- Qualify, document, and validate equipment and processes (test fixtures/Jigs and tools).
- Risk and configuration management of all the technical changes/ECO’s.
- Perform root causes failure analysis of production process/equipment/in-field products.
- DFx methods, including design for manufacturing, testing, and cost optimization, and secure supply chain, addressing quality, schedule, and cost considerations.
- Managing all the ongoing production processes and equipment configuration in the clean room.
- Construction and management of product DMR including BOM, SOP’s, and mechanical and electrical specs.
- Provides technical evaluation and implementation plan input to the corrective action/preventive action (CAPA) program.
- BSc. in Mechanical Engineering.
- 2-4 years’ experience in manufacturing engineering environment of multi-disciplinary products.
- Understanding and knowledge of relevant regulations and standards FDA QSR, ISO 13485, ISO 14971, MDD – an advantage.
- Experience in process validations and qualification IQ/OQ/PQ.
- Experience in process optimization/improvement, lean manufacturing, 5S Root cause analysis & CAPA – an advantage.
- Experience with SolidWorks/PDM.
- Good technical, problem-solving, and hands-on skills.