Sr. Process Development Engineer– Combination Products & Device Engineer
Core
Technical leader and SME for combination products, auto-injectors, and device assembly technologies supporting commercial manufacturing operations.
Role type
Senior IC process development engineer (combination products & devices)
Builds
Automated and semi-automated combination product assembly equipment and processes
Domain
Biotechnology / Medical Devices / Manufacturing
Required skills
GMP compliance, Design of Experiments (DOE), Statistical Process Control (SPC), root cause analysis, equipment validation, technology transfer, regulatory submissions, cross-functional project leadership
Preferred skills
Data-driven engineering principles, Failure Mode and Effects Analysis (FMEA), continuous improvement methodologies, mentorship
Technologies
Automated assembly equipment, GMP manufacturing systems
Responsibilities
Lead development and optimization of automated combination product assembly equipment; Author technical documentation for regulatory submissions and Design History Files; Analyze manufacturing data to evaluate process capability and robustness; Troubleshoot complex manufacturing and equipment issues using statistical problem-solving; Mentor engineers and develop technical capabilities
Seniority
Senior, hands-on IC with technical leadership