Senior Staff Engineer - Process Development, Advanced Operations
Core
Creating work practices and environments to elevate NPI delivery, technical rigor, and manufacturing process development throughout the product lifecycle.
Role type
Senior Staff Engineer (Process Development, Advanced Operations)
Builds
Manufacturing processes, equipment solutions, and validation documentation for new product introductions.
Domain
Medical device manufacturing / Process Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Manufacturing process design, Design for Manufacture/Inspection/Assembly, Statistical analysis (DOE, capability studies), Six Sigma methodologies, GMP compliance, Equipment specification and validation, Cross-functional project leadership
Preferred skills
Lean Six Sigma mindset, FDA-regulated industry experience, Tooling and fixturing supplier management
Technologies
Statistical analysis tools, GMP documentation systems, Engineering drawing interpretation software
Responsibilities
Own critical manufacturing process development workstreams; Conduct experimental testing and DOEs to determine optimal operating parameters; Coach and mentor engineers on NPI delivery and best practices; Lead capital acquisition and equipment validation (IQ/OQ/PQ); Contribute to process technology roadmap and innovation; Lead or provide input into PFMEA, Control Plans, SOPs, and PPAP documentation.
Seniority
Senior Staff, hands-on IC with mentorship responsibilities
