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

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

Unbefristet

Your responsibilities

- Support compliant, efficient, and harmonized technology and product development, as well as lifecycle management activities related to medical device reprocessing
- Perform reprocessing validations according to existing standards and ensure high-quality documentation
- Build and maintain expertise in applicable regulations, standards, and requirements, translating them into streamlined internal processes and documentation
- Support 3rd party laboratory cooperations in terms of project execution and deliverables, e.g., collaboration with external testing laboratories regarding cleaning, disinfection, and sterilization validation of medical devices
- Collaborate with cross-functional teams across the Olympus Group, such as Regulatory Affairs, Quality, Manufacturing Engineering, and Risk Management, and provide internal and external guidance within your area of expertise
- Communicate results to all relevant stakeholders (e.g., Regulatory Affairs, Quality, Risk Management, Manufacturing)
- Support the continuous optimization of applicable QMS processes and reprocessing testing strategies

Your qualifications

- Bachelor’s or Master’s degree in Medical engineering, Microbiology, Natural sciences, or equivalent
- 1 - 2 years of relevant experience in a regulated and highly industrial or scientific environment
- Working knowledge of relevant regulatory requirements, including ISO 17664, MDR 2017/745, ANSI/AAMI ST98, relevant FDA guidance documents and other related reprocessing standards
- Understanding of cleaning, disinfection, sterilization, and validation principles for reusable medical devices
- Solution-oriented working style with strong cross-functional understanding and excellent teamwork skills
- 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
- Basic intercultural competence and understanding of interfaces, stakeholder needs, and the ability to look beyond one’s own area of responsibility

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.