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.
- 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.
- in Mechanical Engineering
- 1-3 years experience in design Engineering & manufacturing environments of multi-disciplinary products in Medical Device companies
- Experience with Process Validations and qualification IQ/OQ/PQ – an advantage
- Knowledge in the following manufacturing technologies: CNC, plastics injections, cable assemblies, PCBA’s – an advantage
- Understanding and knowledge of relevant regulations and standards FDA QSR, ISO 13485, ISO 14971, MDD – an advantage
- Experience with process optimization/improvement, lean manufacturing, 5S, Root cause analysis & CAPA – an advantage
- Experience with SolidWorks