Medical Device & Combination Product (MDCP) Engineer
Core
Drive development, technology transfer, commercialization, and lifecycle management of medical devices and combination products (autoinjectors, pre-filled syringes) in a regulated pharmaceutical manufacturing environment.
Role type
Senior IC MDCP Engineer (Device Development & Technology)
Builds
Semi-automated and fully automated autoinjector assembly systems and combination product kit assembly lines
Domain
Medical Devices / Combination Products / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design controls, Device risk management, Process validation, Automation, Root cause analysis, Change control, Deviation management, QMS documentation, Cross-functional project management, Technology transfer
Preferred skills
Verification testing, TMV, Metrology, Automated assembly support, 5+ years in medical device/pharma/biotech
Technologies
d/pFMEA, QRA, OER, IQ/OQ/PQ, DFM
Responsibilities
Facilitate technology and design transfer from development through commercialization; Contribute to the design, build, and validation of assembly systems; Own technical aspects of investigations for assembly system qualification; Support root cause analyses, CAPA activities, and deviation investigations; Utilize risk management tools to maintain risk management files; Integrate input from multiple stakeholders to drive continuous improvement.
Seniority
Senior, hands-on IC
