Auf einen Blick
- Aufgaben: Unterstütze die Entwicklung und Validierung von Reinigungs- und Sterilisationsprozessen.
- Unternehmen: Olympus Corporation, führend in der Medizintechnik mit innovativen Lösungen.
- Vorteile: 30 Tage Urlaub, mobiles Arbeiten, betriebliche Altersvorsorge und Gesundheitsangebote.
- Weitere Informationen: Dynamisches Team mit hervorragenden Entwicklungsmöglichkeiten und flexiblen Arbeitszeiten.
- Warum dieser Job: Gestalte die Zukunft der Medizintechnik und arbeite an bedeutenden Projekten.
- Qualifikationen: Abschluss in Medizintechnik oder verwandten Bereichen, Erfahrung in der Medizintechnik.
Das prognostizierte Gehalt liegt zwischen 63000 - 77000 € pro Jahr.
As a high-tech specialist within the Olympus Corporation, Olympus Surgical Technologies Europe is the development and manufacturing center for rigid endoscopy, bipolar high-frequency surgery and reprocessing.
With a total workforce of 2,600 employees at nine locations in EMEA and its headquarters in Hamburg, the company stands for exceptional performance in medical diagnostics and therapy, and offers a full range of the most modern endoscopic applications, from single products to procedure-oriented systems solutions.
- Tasks
- Support compliant, efficient, and harmonized technology and product development, as well as lifecycle management activities related to reprocessing and sterilization.
- Lead 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.
- Lead third-party collaborations with external testing laboratories 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.
Qualifications
- Bachelor’s, Master’s in Medical Engineering, Microbiology, Natural Sciences, or equivalent. Ph D in a relevant field is advantageous and will be preferred.
- 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.
- 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.
- 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 inhouse company gym
- #J-18808-Ljbffr
R&D Specialist Reprocessing Execution (m/f/d) Arbeitgeber: Life Science Nord Management GmbH
Wöhlk ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern nicht nur eine wertschätzende Arbeitsumgebung bietet, sondern auch 30 Tage Urlaub, Weihnachts- und Urlaubsgeld sowie betriebliche Altersvorsorge. In Schönkirchen, nur wenige Minuten von der Ostsee entfernt, profitieren die Mitarbeiter von einem starken Wir-Gefühl und der Möglichkeit, in einem innovativen Unternehmen zu arbeiten, das die Contactlinse erfunden hat. Zudem gibt es exklusive Konditionen für Mitarbeiter und zahlreiche Möglichkeiten zur persönlichen und beruflichen Weiterentwicklung.
Kontaktdaten:
Life Science Nord Management GmbH Recruiting-Team
