R&D Specialist Reprocessing Execution (m/f/d) - #2735883

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 qualification - 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