Process Engineer III
Core
Develops and implements equipment upgrades and modifications to reduce product costs and improve product quality for diabetes strip manufacturing operations.
Role type
Process Engineer III (Manufacturing)
Builds
Controlled, repeatable production processes and equipment for medical devices
Domain
Medical device manufacturing (diabetes care)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
mechanical or chemical engineering principles, design controls (ISO13485, FDA), statistical analysis, tolerance analysis, process optimization, engineering calculations, writing process specifications, GxP compliance
Preferred skills
master's degree, mid-volume manufacturing experience
Technologies
FDA guidelines, ISO13485, Design Control procedures
Responsibilities
Specify, design, verify and validate new manufacturing processes and equipment; troubleshoot process equipment and perform process optimization; conduct pFMEAs, DOEs, and validation protocols; write and submit Engineering Change Orders; utilize and maintain the effectiveness of the quality system; participate in technical design reviews
Seniority
Mid-level, hands-on IC
