Associate Principal Engineer, Drug-Device Combination Products
Core
Hands-on medical device product manufacturing and assembly engineer for combination products (autoinjectors, inhalers, implants, etc.), leading equipment development and process validation from conception to launch.
Role type
Senior IC medical device manufacturing and assembly engineer
Builds
Automated combination product assembly equipment and validated manufacturing processes
Domain
Medical devices / Combination products / Manufacturing engineering
Required skills
Combination product assembly, Process validation (IQ/OQ/PPQ), FMEA, Design for Manufacturing/Assembly (DFM/DFA), Equipment supplier management, Vision systems, Ultrasonic welding, Automated component handling, Manufacturing site readiness, Mechanical troubleshooting
Preferred skills
CAD (SOLIDWORKS), 3D printing, Custom fixture design
Technologies
SOLIDWORKS, Vision systems, Ultrasonic welding, Automated feeding systems
Responsibilities
Develop detailed plans for combination product assembly processes and equipment; Author design/process FMEA and risk controls; Design and author process validation documentation (IQ, OQ, PPQ); Manage equipment suppliers and manufacturing site readiness; Troubleshoot assembly equipment and processes; Support technology transfer to manufacturing facilities
Seniority
Senior, hands-on IC
