- Design, evaluate, implement and monitor processes and operating systems for the manufacture aortic stent grafts
- Develop and implement new mfg processes, execute process validations such as IQ, OQ, PQ protocols and reports
- Lead the design transfer phase including product development, validation planning, design for manufacturability and assembly, Design of Experiments, process capability analysis, etc.
- Conduct risk analysis including DFMEA, PFMEA and create/maintain necessary documentation.
- Support the conversion of small-scale processes into commercially viable large-scale operations.
- Monitor and improve the efficiency, output and safety of manufacturing processes through observations and measurements as well as by collecting and interpreting data from other technical and operating personnel.
- Other various responsibilities and projects, as necessary
- 4 - year engineering degree or equivalent experience
- 3+ years of experience in a technical role in the medical device industry
- Project management experience in the medical device industry
- Experience and understanding of quality system regulations (e.g. 21CFR820, ISO13485).
- Project management experience in the medical device industry
- Experience with polymers, medical grade metals and medical packaging
- Hands-on knowledge of electronics, motion control, plastics, metallurgy, and manufacturing processes
- Experience with polymers, medical grade metals and medical packaging
Please send suitable resumes in confidence to JPCuadra @ openscientific.com
All your information will be kept confidential according to EEO guidelines.
