The New Product Introduction (NPI) process engineer will provide Dermcut Medical Pte Ltd with technical support and operating knowledge for our medical device operation. This role will conduct critical engineering functions such as product validation, troubleshooting, identifying and implementing process improvements.
The engineer will work closely with project manager and is in charge of taking the prototype from pilot scale into full scale manufacturing in support of commercial efforts. This position will focus on developing various processes and implementing those to support mass production.
Primary Responsibilities
- Establish processes based on product specifications.
- Develop control plans, gage repeatability & reproducibility, test method verification & validation, and pFMEA.
- Identify areas of process improvement to reduce and minimize process related nonconformance incidents and to maximize efficiency of the process.
- Co-ordinate the generation of dossier including but not limited to design files, technical files and project files to include design outputs, shelf-life studies, biocompatibility, sterilisation, risk analysis, validation master plans, IQ's, OQ's, PQ's and test regimes.
- Responsible for screening and optimization of process parameters to achieve robust and stable processes and maximize yields, efficiencies and process capabilities.
- Perform other related duties and responsibilities as assigned.
Education / Experience Requirements
- Bachelor’s degree in process engineering or similar qualification.
- A minimum of 2 years’ experience in the medical device industry.
- A strong understanding of validation strategy (IQ/OQ/PQ), support protocols and reports.
- Experience in root cause analysis of technical discrepancies/abnormalities.
- Familiar with FDA documentation requirements, ISO 13485 quality management system, lean manufacturing, and good manufacturing practice.
- Experience with SolidWorks and Microsoft Project preferred.
