Occlutech is the leader in developing innovative products for the treatment of structural heart disease. The Company sells and markets occluders indicated for the repair of structural heart defects or valvular leaks, including a range of custom occlusion devices and accessories, in well over 50 markets around the world. Occlutech operates facilities in Germany, Turkey and Sweden. For additional information please visit our website at www.occlutech.com .
Test Engineer / Specialist (m/f) LOCATION: Jena, Germany
REPORTS TO: R&D Manager GmbH
POSITION DESCRIPTION:
The new position as test Engineer will be responsible for structuring the testing at R&D and together with the R&D Team develop new methods for supporting the development both internal and external organizations, test expert also making sure that the testing meets the legal requirement. The ideal candidate will work in close collaboration with R&D and Quality departments at the Company’s sites in Germany, Turkey and Sweden. Moderate travel will be required.
PRINCIPAL RESPONSIBILITIES:
Together with R&D and the quality department, the Test Engineer/Specialist will be responsible for:
• Working with R&D in development projects up to the technical transfer activities to Q-department
• Establishing test strategies
• Documentation of test methods and results in suitable databases
• Data management and process monitoring activities (Statistical Process Control)
• Coordinating and participating in the drafting of procedures, protocols, reports
• Supporting RA/QA for local and international audits (Notified Bodies, ANVISA, U.S.FDA, SFDA, KFDA, etc.)
• Planning and reporting in the above mentioned areas (updated budgets, timetables, and other)
REQUIREMENTS:
• University degree required
• Minimum of 6 years of aggregate experience working in the medical with practical test method development work
• Knowledge of and experience with regulations and guidelines pertaining to the medical device industry, including ISO 13485, CFR 820 and Medical Device Directive
• Experience with:
– Test method development for performance and endurance tests
– Data management
– Technical investigations and change controls
• Excellent leadership, interpersonal and communication skills
• Ability to effectively work in a fast-paced, multicultural environment
• Hands-on working style
• Excellent spoken and written English and German a must
APPLICATION PROCESS:
Applicants must provide a CV & cover letter stating their interest in the position and their qualifications. References will be required. Only English applications will be considered.
Occlutech GmbH
att: Katrin Biedermann
Wildenbruchstraße 15
D-07745 Jena
katrin.biedermann@occlutech.com
phone: +49(0)3641-675120
www.occlutech.com
Bitte geben Sie bei Ihrer Bewerbung folgende Referenznummer an: JD-509848