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

Olympus Corporation; Hamburg; Hybrid; EUR 52.000 - 76.000; Vollzeit

Benefits dieser Stelle

30 days annual leave

Mobile work up to 60% + flexible time

Holiday and Christmas bonuses

Corporate benefits discounts

Company pension scheme and capital‑acc

Company restaurant with live cooking

Employee Assistance Program

Deutschlandticket subsidy and parking

Inhouse gym access

Zusammenfassung

Olympus Corporation is seeking a scientifically minded professional to validate reprocessing steps for medical devices in a regulated environment. You will interpret standards, document results, and support collaboration with external labs to ensure compliant cleaning, disinfection, and sterilization validation.

You will work with Regulatory Affairs, Quality, Manufacturing Engineering and Risk Management teams to streamline processes and improve the QMS.

Qualifikationen

• 1–2 years of relevant experience in a regulated environment.
• Working knowledge of ISO 17664, MDR 2017/745, ANSI/AAMI ST98 and FDA guidance.
• Understanding of cleaning, disinfection, sterilization, and validation principles for reusable medical devices.
• Strong teamwork, cross-functional understanding, and solution-oriented mindset.
• Ability to interpret technical drawings and document results clearly.

Aufgaben

• Perform reprocessing validations according to standards and ensure high-quality documentation.
• Build expertise in applicable regulations and streamline internal processes.
• Support external lab collaborations for cleaning, disinfection, and sterilization validation.
• Collaborate with Regulatory Affairs, Quality, Manufacturing Engineering, and Risk Management.
• Communicate results to stakeholders across Regulatory Affairs, Quality, Risk Management, and Manufacturing.
• Support continuous optimization of QMS processes and reprocessing testing strategies.

Kenntnisse

English communication

Cross-functional collaboration

Intercultural competence

Read technical drawings

Documentation of results

Ausbildung

Bachelor's or Master’s degree in Medical engineering / Microbiology / Natural sciences

Tools

MS Office

Jobbeschreibung

Your Responsibilities

• 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