Prozessingenieur Medizintechnik (w/m/d)
Core
Bridge production technology and quality assurance, ensuring technical manufacturing processes meet system performance and quality standards for medical devices.
Role type
Process Engineer (Medical Devices)
Builds
Production processes and GMP documentation for medical device manufacturing
Domain
Medical Devices / Biotech / Pharma
Required skills
Process qualification and validation, GMP compliance, ISO 13485 and ISO 9001 knowledge, Statistical experimental design, Project management, Cost and delivery monitoring
Preferred skills
Master's degree in Chemical Engineering, 3-5 years experience in process-controlled manufacturing
Technologies
GMP, DIN EN ISO 9001, ISO 13485, Statistical methods
Responsibilities
Act as a link between production technology and quality assurance, Develop innovative ideas for optimizing existing production processes, Ensure regulatory approval prerequisites, Create and maintain GMP documentation, Monitor company goals regarding quality, costs, delivery performance, and schedule