1. Responsible for the process development and validation of medical device assembly & component manufacturing processes
2. Establish validation standards, develop master validation plan and complete all necessary validation documentation
3. Generate IQ, OQ,PQ Protocol Document
4. Evaluate manufacturing processes and formulate process work instructions for process validations & production.
5. Assist to develop process parameters using tools such as Design of Experiments and engineering study
6. Work with cross-functional team to ensure smooth delivery of medical device process validations
7. Able to apply continuous improvement best practices tools like Lean, DMAIC or Value Stream Mapping to improve the manufacturing processes
8. Ensure manufacturing processes are running according to specifications and incompliance with quality objectives & regulatory requirements
9. Able to identify& help to resolve project issues and conflicts within the project team
10. Any other duties as assigned
Diploma / Degree in Mechanical Engineering
- experience in process development andvalidation
- experience in statistical analysis
- Experience in polymer processes (injection molding, blow molding, extrusion, LSR) and assembly processes
- Good interpersonal skills in order to work with cross-functional teams
- Experience with Medical Device Directive(MDD), ISO 13485, FDA design controls or similar regulatory environment
- Experience in Medical Device with practical knowledge of manufacturing & engineering SOP’s in a regulated environment(FDA 21 CFR Part 820 or equivalent)
