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 patients and users. This position requires a deep understanding of biocompatibility testing, materials science, and regulatory guidelines. Your responsibilities include 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 #

• Perform biological risk assessments, including the definition and implementation of risk control measures.
• Develop and manage biocompatibility test plans; oversee execution and reporting in collaboration with external testing providers.
• Manage biological safety campaigns for our products in line with regulatory requirements.
• Prepare biocompatibility documentation to support international regulatory submissions (with a strong focus on U.S. and Europe).
• Drive continuous improvement of testing methodologies and support internal/external audits.
• Develop hygiene concepts and cleaning strategies for our product portfolio.

Your profile #

• Bachelor’s or master’s degree in Life Sciences, Biomedical Engineering, or related field.
• At least 5 years of experience in the medical device industry or a comparable regulated environment.
• Proven experience in preparing successful biological safety submissions to regulatory bodies.
• In-depth knowledge of ISO 10993, ISO 17664, MDR 2017/745, FDA guidance, and relevant biocompatibility standards.
• Expertise in materials science, toxicology, and their application to medical devices.
• Analytical and risk-based mindset aligned with business and regulatory priorities.
• Strong written and verbal communication skills in 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.