Biological Safety Engineer
- Performance of biological risk assessment, including definition and management of risk control measures.
- Biological safety testing, including creation of test plans, test execution, and reports based on results supplied by external testing providers.
- Management of biological safety campaigns for our products in line with regulatory requirements.
- Contribution to the continuous improvement of testing methodologies and of processes pertaining to development, manufacturing, and risk assessment.
- Development of hygiene concepts for our product portfolio.
- Min. Bachelor’s degree in a life science discipline, or equivalent education
- Min. 5 years’ industry experience in the field of medical devices or similar area.
- Proven track record of successful biological safety submissions to regulatory bodies.
- Thorough understanding and experience with ISO 10993 and ISO 17664 standard series, as well as MDR 2017/745 and FDA guidance, medical device development, and manufacturing processes.
- Expertise in materials science, toxicology, and their application to medical devices.
- Risk-based thinking in line with business needs.
- Excellent problem-solving skills.
- Strong written and verbal communication skills (English, German is a plus), with the ability to communicate complex technical information clearly.
- Excellent interpersonal skills and experience in a cross-functional, international environment.
We are looking for passionate people who can easily identify with our company, who bring drive, expertise, and good vibes to our enterprise. People who appreciate the community and know that sharing talents and information to achieve common goals and objectives is the best way to develop.
Zürich / Zurich