Olympus Winter & Ibe GmbH (OWI)Chief Technology OfficerUnbefristet
Type of employment:
Permanent employment
Function:
Research & Development
Reference Number:
80227706-29062026
Website:
https://www.olympus-oste.eu
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
