Senior Manufacturing Process Development Engineer
Core
Designing and developing manufacturing processes for life sciences products, specifically medical devices like diabetes strips, ensuring transfer from research to mass production.
Role type
Senior Manufacturing Process Development Engineer
Builds
Economical mass production processes and procedures for medical devices
Domain
Medical devices / Life sciences manufacturing
Required skills
Mechanical or chemical engineering principles, Design controls (ISO13485, FDA), Statistical analysis, Tolerance analysis, Process requirements writing, GxP compliance, Cross-functional collaboration
Preferred skills
Experience with diabetes strip manufacturing, Low cost high volume design, Pilot-plant operations
Technologies
ISO13485, FDA regulations, GxP, Statistical analysis tools
Responsibilities
Develop procedures for economical mass production, Conduct tests and measurements to control production variables, Troubleshoot and solve production process problems, Perform complex engineering calculations and statistical analysis, Write process/product requirements and design specifications, Work in FDA regulated environment
Seniority
Senior, hands-on IC