(Senior) Process Engineer (m/w/d) Product Transfers - befristet auf 24 Monate
Core
Provide engineering support for product transfers, ensuring activities and documentation comply with Stryker procedures and regulatory requirements.
Role type
Senior Process Engineer (Product Transfers)
Builds
Validated manufacturing processes, component-specific testing protocols, and qualification documentation for medical devices.
Domain
Medical Devices / Manufacturing Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mechanical and structural design judgment, reading complex engineering drawings, GD&T interpretation, process validation, PFMEA, Control Plan, SOP, PPAP development, GMP adherence, equipment selection based on reliability specs.
Preferred skills
FDA regulated industry experience, Medical Device industry experience, Process/Product validation, Statistical methods, Process mapping, Continuous Improvement, Project/Process Improvement, Green or Black Belt Six Sigma.
Technologies
PFMEA, Control Plan, SOP, PPAP, GMP, Six Sigma
Responsibilities
Determine technical objectives and direction for engineering assignments, monitor and control work progress, analyze equipment for operating data and experimental testing, mentor others on functional topics, ensure quality of process and product against specifications, select components and equipment based on analysis, participate in internal process qualification generation, review and approve validation documentation.
Seniority
Senior, hands-on IC
