Human Xtensions is a rapidly growing startup, developing breakthrough technology in the field of robotic Minimally Invasive Surgery (MIS). We’re looking for an awesome engineer to join our core engineering team that is reshaping MIS.
This position conducts engineering activities and tasks in support of manufacturing requirements.
- Design improvements from design freeze and during mass-production.
- Design, qualify, document, and validate assembly & test fixtures/Jigs and tools.
- DFx methods (Design for manufacturing, testing, cost optimization) Design and secure Supply chain -Quality, Schedule, Cost.
- Performs root causes analysis on equipment and manufacturing process issues.
- Support ongoing production processes and equipment, training of subcontractors & production line.
- Creating work and testing instructions, production and assembly instructions.
- Provides technical evaluation and implementation plan input to the Corrective Action/Preventive Action (CAPA) program.
- Construction and management of product DMR including BOM, SOP’s, Mechanical & electrical specs.
- Configuration management and Implementation of Engineering Changes/ECO.
- BSc. in Mechanical Engineering
- Understanding and knowledge of relevant regulations and standards FDA QSR, ISO 13485, ISO 14971, MDD
- 4+ years experience in design Engineering & manufacturing environments of multi-disciplinary products in Medical Device companies
- Excellent understanding of the following: complex machined parts, plastics injections, cable assemblies, PCBA
- Experience with Process Validations and qualification IQ/OQ/PQ
- Experience with process optimization/improvement, lean manufacturing, 5S, Root cause analysis & CAPA.