Staff Manufacturing Engineer
Core
Lead cross-functional development, validation, and implementation of manufacturing processes for continuous glucose monitoring (CGM) applicator technology to support new product introductions and commercial production readiness.
Role type
Staff Manufacturing Engineer (Medical Devices)
Builds
CGM applicator devices and manufacturing processes
Domain
Medical Devices / Biosensing Technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
process validation, statistical tools (DOE, SPC, Gauge R&R), root cause analysis, PFMEA, change control, project management, cross-functional leadership, technical mentoring
Preferred skills
pilot-scale or high-volume manufacturing expertise, equipment qualification, measurement systems analysis, regulated industry experience
Technologies
DOE, SPC, Gauge R&R, IQ/OQ/PQ protocols, CAPA
Responsibilities
Lead cross-functional development and validation of manufacturing processes; Drive process capability, quality, and yield improvements using statistical tools; Own process validation activities including IQ/OQ/PQ protocols; Provide technical leadership and project management for complex engineering initiatives; Assess and mitigate process and product risks via PFMEAs and change control; Mentor engineers and establish best practices for long-term process improvement
Seniority
Staff, hands-on IC with strategic influence