Principal Process Engineer, Advanced Manufacturing Team
Core
Technical leader defining and advancing manufacturing strategies for the development, commercialization, and scale-up of life-saving medical technologies.
Role type
Principal Process Engineer (Advanced Manufacturing)
Builds
Manufacturing processes, technology roadmaps, and process control strategies for new product introductions and commercialized medical devices.
Domain
Medical device manufacturing / Advanced Manufacturing Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Advanced manufacturing process development, technology roadmap definition, cross-functional collaboration, process validation (IQ/OQ/PQ), root cause analysis, Lean Six Sigma, capital planning, equipment selection, facility design, technical mentorship, enterprise-wide standardization, executive-level communication.
Preferred skills
Medical device/pharma/biotech manufacturing experience, automation/robotics/digital manufacturing expertise, plastics processing technologies, risk management (FMEA), Lean Six Sigma Black/Master Black Belt.
Technologies
Automation solutions, robotics, digital manufacturing tools, statistical methods (DOE, SPC), data analytics platforms.
Responsibilities
Serve as technical authority for advanced manufacturing processes; lead development and optimization of complex manufacturing processes; define manufacturing architectures and technology roadmaps; drive cross-functional collaboration with R&D, Quality, Operations, and Supply Chain; implement emerging manufacturing technologies and automation; lead process characterization, risk assessments, and technology transfers; establish robust process control strategies; provide technical leadership for process validation; lead investigations into critical manufacturing issues; champion continuous improvement initiatives; influence capital planning and facility design; mentor and develop engineers; lead enterprise-wide standardization initiatives; represent manufacturing engineering in executive reviews.
Seniority
Principal, technical leadership & strategy