Biological Safety Engineer
About the position #
Your key role is to ensure the safety and regulatory compliance of our medical devices regarding their biological safety, focusing on minimizing risks to the patient or user. This position requires a deep understanding of biocompatibility testing, materials science, and regulatory guidelines. Your responsibilities are Biocompatibility Assessment, Cleaning and Disinfection, Re-Processing, and Product Aging. Do you want to help us to make lung function testing accessible to everyone everywhere, and to improve the lives of millions of people living with lung diseases? Then you have come to the right place.
Why us? #
We offer an attractive location, fair pay, good social benefits, flexible working hours, and the best conditions in which to do excellent work. This includes comprehensive onboarding, professional and modern technology, and a collegial and supportive working environment. We promote equal opportunities, diversity, and inclusion.
If this profile describes you and you would like to work at a fast-growing company in a global environment, then we should meet. Apply directly and exclusively via our e-recruiting tool. The more we learn about you, the better. We look forward to receiving your complete application and reference letters. Your data will be treated confidentially and discreetly.
Tasks #
- 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.
Your profile #
- 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.