Beschreibung

In this role, you will focus on evaluating the biocompatibility of medical devices, conducting safety assessments, and coordinating testing strategies. Your expertise will help ensure compliance with regulatory standards while supporting innovative product development.

Anforderungen

• •Master’s degree in scientific, engineering, or similar technical field
• •Related working experience: 2–8 years
• •Highly experienced in writing biocompatibility evaluations
• •Deep 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
• •Strong knowledge of medical device risk management process and related regulations
• •Experience with product or design and development or quality engineering of sterile disposables utilizing various plastic processes
• •Ability to communicate technical information to non-technical audiences
• •Familiar with agile methodology
• •Proven track record in project and/or test management
• •Proficient with ALM and PDM systems
• •Familiar with durables and disposables of medical devices
• •Fluent 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 according to MDR and ISO 10993
• •Perform safety and risk assessments based on raw materials and biocompatibility studies
• •Plan and interpret analytical and biological tests from internal or external labs
• •Compile biological safety assessments per ISO 10993-1
• •Develop biocompatibility strategies for new products and material changes
• •Act as sponsor and monitor for chemical and biocompatibility studies
• •Coordinate support for biocompatibility projects and overarching strategies
• •Align sampling and testing strategies with product teams
• •Coordinate global laboratory partnerships and applied methods
• •Manage biocompatibility files for assigned product groups
• •Contribute to supplier agreements and specifications for biocompatibility
• •Monitor regulatory changes and ensure timely implementation of methodologies

Tools & Technologien