Senior Process Engineer
Core
Lead or support new product introduction projects to achieve quality, delivery, and cost goals in the medical device industry.
Role type
Senior Process Engineer (New Product Introduction)
Builds
New medical device products and manufacturing processes
Domain
Medical Devices / Manufacturing Engineering
Required skills
CNC machining knowledge, Blueprint reading, Statistical process control, Process validation (IQ/OQ/PQ), Engineering risk analysis, GMP compliance, Equipment specification and validation, Data analysis
Preferred skills
CNC programming, Medical device industry experience, Process quality assurance experience, Engineering degree (B.S. or above), Stryker experience
Technologies
Excel, Word, PowerPoint, CNC machines
Responsibilities
Identify effective assembly techniques and manufacturing processes from concept to launch, Design and implement inspection and testing methods, Analyze reports and recommend corrective actions, Participate in PFMEA, Control Plan, SOP, and PPAP generation, Develop and execute process validation protocols, Lead process development including flowcharts and logistics, Optimize operating parameters to increase capabilities and lower costs, Interface with R&D, Manufacturing, Quality, and vendors to meet regulatory and cost standards
Seniority
Senior, hands-on IC