Senior Engineer, Product Transfer
Core
Senior engineer leading product transfers, ensuring engineering support, technical objective determination, and process validation for manufacturing projects.
Role type
Senior IC mechanical/structural engineer (product transfer)
Builds
Validated product transfer processes and equipment configurations
Domain
Medical device manufacturing / FDA-regulated industry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
mechanical and structural design, reading complex engineering drawings, geometrical dimensioning and tolerancing (GD&T), process validation, PFMEA, Control Plan, SOP, PPAP, GMP compliance, component selection based on reliability and regulatory requirements, experimental test and result analysis, mentoring
Preferred skills
FDA regulated industry experience, process/product validations, statistical methods, process mapping, continuous improvement, project/process improvement, Green or Black Belt Six Sigma
Technologies
PFMEA, Control Plan, SOP, PPAP, GMP
Responsibilities
Provide engineering support for product transfers ensuring activities are completed and documented per procedures, determine technical objectives and direction of engineering assignments, monitor and control work progress, analyze equipment to establish operating data and conduct experimental tests, coach and mentor others, ensure quality of process and product, select components and equipment based on specifications and regulatory requirements, participate in process qualification generation, review and approve validation documentation
Seniority
Senior, hands-on IC with mentorship