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

• R&D Specialist Reprocessing Intelligence (m/f/d)
• Olympus Winter & Ibe Gmb H (OWI) Chief Technology Officer
• Your Responsibilities
• Support compliant, efficient, and harmonized technology and product development, and 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. Ph D 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 Fam PLUS 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 in‑house 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.

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