Sr Device Assembly Engineer
Core
Provide technical leadership for the commercial ConfiPen device assembly platforms throughout the product lifecycle, ensuring safety, quality, and regulatory compliance for drug-device combination products.
Role type
Senior IC device assembly engineer (medical devices)
Builds
Automated assembly equipment, force-displacement monitoring systems, and drug-device combination products
Domain
Biotechnology / Medical Device Manufacturing
Deliverable
production ML models | product features | infrastructure
Required skills
Medical Device Design Control regulations (21 CFR 820.30), Design of Experiments (DOE), root cause analysis, statistical process control, automated assembly systems, force-displacement monitoring, Design History Files, DFMEA/PFMEA
Preferred skills
None stated
Technologies
Automated assembly equipment, force-displacement monitoring systems, in-process monitoring systems
Responsibilities
Lead design change implementation and lifecycle management for commercial devices; Execute Design of Experiments (DOE) to optimize assembly processes; Lead troubleshooting of automated assembly and testing equipment; Support technology transfer to manufacturing lines; Author engineering protocols and technical documentation for regulatory submissions; Lead root cause investigations for quality events and device failures.
Seniority
Senior, hands-on IC with technical leadership