Senior Engineer, Product Transfer (m/f/d) Medical Devices
Core
Manage internal equipment/process transfers at the Tuttlingen site and transfer products to German suppliers, ensuring high-quality standards and regulatory compliance.
Role type
Senior IC manufacturing engineering specialist (product transfer)
Builds
Validated production processes and equipment transfers for medical devices
Domain
Medical devices manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
process/product validation, statistical methods, process mapping, equipment analysis, experimental testing, regulatory compliance (ISO 13485, FDA 21 CFR Part 820), problem-solving in manufacturing
Preferred skills
ISO 13485, FDA 21 CFR Part 820, global quality standards
Technologies
Validation, PFMEA, Control Plan, SOP, PPAP
Responsibilities
Define technical objectives for engineering assignments, monitor and control work progress, analyze equipment to establish operating data, participate in creation of validation and process qualification documents
Seniority
Senior, hands-on IC