Associate Principal Engineer, Drug-Device Combination Products
Core
Hands-on medical device product manufacturing and assembly engineer for combination products (autoinjectors, inhalers, implants, infusion pumps, vaginal rings, connected devices/apps), focusing on factory floor work, equipment development, and process validation.
Role type
Associate Principal Engineer, Medical Device Manufacturing & Assembly
Builds
Automated combination product assembly equipment and validated manufacturing processes for clinical and commercial use
Domain
Medical Devices / Combination Products / Manufacturing Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Combination Product Assembly, Automated Equipment Design, Process Validation (IQ/OQ/PPQ), FMEA, DFM/DFA, Equipment Supplier Management, Troubleshooting, Manufacturing Site Readiness, Vision Systems, Ultrasonic Welding, Glass Feeding Systems
Preferred skills
CAD Modeling (SOLIDWORKS), 3D Printing, Custom Fixture Fabrication
Technologies
SOLIDWORKS, Vision Systems, Ultrasonic Welding, Automated Component Handling
Responsibilities
Develop detailed plans and strategies for combination product assembly process and equipment development; Author design/process FMEA to capture risks and identify controls; Design and author Process validation activity and documentation (IQ, OQ, PPQ); Manage equipment suppliers and troubleshoot assembly equipment processes; Support process and technology transfer to manufacturing facilities
Seniority
Senior, hands-on IC