our Responsibilities

- Support compliant, efficient, and harmonized technology and product development, as well as lifecycle management activities related to reprocessing and sterilization.

- Guide cleaning, disinfection, and sterilization validation activities according to applicable standards and regulations while ensuring high-quality documentation.

- Serve as the technical contact person for peers and subject matter expert for reprocessing and sterilization-related topics.

- Build and maintain expertise in applicable regulations, standards, and requirements (e.g., ISO 17664 series, MDR 2017/745, ANSI/AAMI ST98, relevant FDA guidance documents), translating them into streamlined internal processes and documentation.

- Guide third-party collaborations with external testing laboratories and internal laboratory regarding cleaning validation, disinfection efficacy, and sterilization validation studies.

- Collaborate with cross-functional teams across Regulatory Affairs, Quality, Risk Management, Manufacturing Engineering, and R&D.

- Communicate validation strategies, study outcomes, and technical recommendations to relevant stakeholders (e.g., Regulatory Affairs, Quality, Risk Management, Manufacturing).

- Support investigations, change management activities, CAPAs, and continuous improvement of QMS processes and testing strategies.

- Participate in internal and external audits and provide expert support for technical and regulatory questions.

Your qualification

- Bachelor’s, Master’s in Medical Engineering, Microbiology, Natural Sciences, or equivalent. PhD in a relevant field is advantageous

- 2-5 years of relevant experience in medical device reprocessing, sterilization, microbiology, or a related regulated environment.

- Strong knowledge of ISO 17664 series, MDR 2017/745, and medical device development processes.

- Experience with cleaning validation, sterilization validation, and reusable medical device reprocessing will be preferred.

- Experience with change management, non-conformities (NCs), and CAPAs is beneficial.

- Strong cross-functional understanding, project leadership capabilities, and solution-oriented working style.

- Ability to interpret technical drawings and mechanical designs

- Good verbal English skills; a clear communication style will be appreciated.

- Good written English skills; experience with documentation of scientific results is preferred.

- Good knowledge of MS Office.

- Anticipate interfaces, the need of others and having the ability to look beyond one's own nose.

Your benefits

- 30 days of annual leave

- Up to 60% mobile work possible + flexible work time model with overtime compensation

- Holiday and Christmas bonuses

- Corporate benefits discounts for employees

- Comprehensive company pension scheme and capital-forming benefits

- Company restaurant with live cooking and healthy food (subsidized)

- Employee Assistance Program of FamPLUS to support your health, mental and emotional well-being

- Subsidy for public transportation (Deutschlandticket), free parking spaces and bike or car leasing

- Various subsidized company sports groups and access to the inhouse company gym