Intern, NPI &Test Engineering
Core
Support New Product Introduction (NPI) and Test Engineering for medical device manufacturing, focusing on risk mitigation, process compliance, and documentation.
Role type
Intern, NPI & Test Engineering
Builds
Medical device manufacturing processes and insulin pump delivery systems
Domain
Medical Devices / Biotechnology / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Engineering fundamentals, cGMP compliance knowledge, FDA 21CFR820 guidelines, ISO 13485 standards, pFMEA analysis, project tracking, process documentation, cross-functional collaboration
Preferred skills
Data analytics, multi-language fluency (English, Malay, Mandarin), adaptability to equipment issues
Technologies
MS Office (Word, Excel, PowerPoint, Outlook), project trackers
Responsibilities
Execute pFMEA remediation actions across manufacturing lines, review and analyze process risks, track remediation activities and closure status, update process documentation (work instructions, flow diagrams, control plans), prepare project status reports for management, support cross-functional meetings with Manufacturing, Quality, and Engineering teams
Seniority
Intern