Manager - Process Engineering
Core
Lead technical strategy and execution for process development, characterization, and pilot manufacturing of continuous glucose monitoring (CGM) devices in a regulated environment.
Role type
Senior IC Process Engineering Manager (Manufacturing)
Builds
Robust manufacturing processes, pilot-scale equipment, and product transfer for CGM devices
Domain
Medical device manufacturing / Biosensing technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process development and characterization, Design of Experiments (DOE), statistical analysis (Gauge R&R, Cp/Cpk, SPC), GMP/GLP operations management, FDA 21 CFR 820 and ISO 13485 compliance, cross-functional collaboration, NPI roadmap management, team leadership and mentoring
Preferred skills
DMAIC process knowledge, Lean manufacturing, project management, STEM degree background
Technologies
Pilot manufacturing lines, specialized analytical testing tools, statistical software
Responsibilities
Lead process development and characterization for new products; oversee DOE execution and data interpretation; manage documentation and experimental requests on pilot lines; monitor pilot line performance and drive continuous improvement; oversee process transfer from development to pilot operations; collaborate with R&D, Quality, and Operations on validation strategies; provide hands-on technical guidance for manufacturing workflows; champion NPI strategies; select and mentor engineering talent; ensure compliance with safety, environmental, and quality standards
Seniority
Senior, hands-on IC with management responsibilities