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

Olympus Corporation; Hamburg; Vor Ort; EUR 65.000 - 95.000; Vollzeit

Benefits dieser Stelle

30 days annual leave

Hybrid work options

Holiday and Christmas bonuses

Corporate discounts

Company pension scheme

Zusammenfassung

Olympus Corporation seeks a qualified professional to lead cleaning, disinfection, and sterilization validation activities in a regulated medical device environment in Hamburg. You will act as a technical contact for reprocessing topics, liaise with Regulatory Affairs, Quality, and Manufacturing, and ensure compliant documentation across projects.

Ideal candidates hold a degree in medical engineering with 2–5 years experience; knowledge of ISO 17664, MDR 2017/745, and validation methods is

Qualifikationen

• Bachelor's/Master's in a relevant field; PhD advantageous.
• 2-5 years of relevant experience in medical device reprocessing, sterilization, or related regulated environment.
• Strong knowledge of ISO 17664, MDR 2017/745, and medical device development processes.

Aufgaben

• Guide cleaning, disinfection, and sterilization validation activities with documentation.
• Serve as technical contact for reprocessing topics and SME for related areas.
• Translate regulations and standards into streamlined internal processes and documentation.
• Lead collaborations with external labs and internal teams on validation studies.
• Collaborate with Regulatory Affairs, Quality, Risk, Manufacturing, and R&D.

Kenntnisse

Medical device reprocessing

Sterilization validation

Regulatory knowledge

Project leadership

Cross-functional collaboration

English communication

Ausbildung

Bachelor's degree in Medical Engineering or related

Master's degree in Medical Engineering or related

PhD advantageous

Tools

MS Office

Jobbeschreibung

Your Responsibilities

• 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. PhD 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 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