R&D Specialist Reprocessing Execution (m/f/d)

R&D Specialist Reprocessing Execution (m/f/d)

As a high-tech specialist within the Olympus Corporation, Olympus Surgical Technologies Europe is the development and manufacturing center for rigid endoscopy, bipolar high-frequency surgery and reprocessing. With a total workforce of 2,600 employees at nine locations in EMEA and its headquarters in Hamburg, the company stands for exceptional performance in medical diagnostics and therapy, and offers a full range of the most modern endoscopic applications, from single products to procedure-oriented systems solutions.

Your responsibilities

- Support compliant, efficient, and harmonized technology and product development, as well as lifecycle management activities related to reprocessing and sterilization.
- Lead 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.
- Lead third-party collaborations with external testing laboratories 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 qualifications

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

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

Further information

Your future inclusive workplace awaits

We value the diversity of individuals, perspectives, and lifestyles, and prioritize inclusion and mutual respect. We are committed to fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish.
We warmly encourage all who wish to bring their talents to Olympus to apply.