Beschreibung

In this role, you will focus on evaluating the biocompatibility of medical devices, supporting safety assessments, and coordinating testing strategies. Your day-to-day responsibilities will involve collaborating with laboratories and ensuring compliance with regulatory standards.

Anforderungen

• •Bachelor’s or master’s degree in scientific, engineering, or similar technical field
• •1 to 5 years of related working experience
• •First experience in writing biocompatibility evaluations
• •Knowledge of biocompatibility testing and evaluations of medical devices according to ISO 10993
• •Application of Design Control and Risk Management, knowledge of FDA CFR 820, ISO 13485, and ISO 14971
• •Knowledge of medical device risk management process and related regulations
• •Experience with product or design and development or quality engineering of sterile disposables
• •Ability to communicate technical information to non-technical audiences
• •Familiarity with agile methodology
• •First experience with ALM and PDM systems
• •Familiarity with durables and disposables of medical devices
• •Fluency in German and English, both written and spoken
• •Willingness to travel on an average monthly cadence and to work in different time zones

Aufgaben

• •Evaluate biocompatibility of medical devices
• •Support safety and risk assessments based on raw materials
• •Interpret and evaluate analytical and biological tests
• •Assist in compiling biological safety assessments
• •Derive biocompatibility strategy details
• •Act as sponsor and monitor for biocompatibility studies
• •Coordinate biocompatibility project support
• •Align sampling and testing strategies
• •Coordinate global laboratory partner alignment
• •Manage biocompatibility files for assigned product groups
• •Contribute to supplier agreements for biocompatibility
• •Monitor regulation changes and ensure timely implementation

Tools & Technologien

Benefits