Process Development Engineer / Project Leader (m/f)

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 .

Process Development Engineer / Project Leader (m/f)
LOCATION: Jena, Germany
REPORTS TO: R&D Manager GmbH

POSITION DESCRIPTION:

The successful candidate will be responsible for process development of our next generation developments of Class III cardiovascular devices. The work is carried out as team member in project teams or as a project leader in a process project, depending on your experience. The individual will work in close collaboration with Manufacturing at the Company’s sites in Germany, Turkey and Sweden. During the initial year intensive travel will be required to our site Cologne.

PRINCIPAL RESPONSIBILITIES:

• Develop processes and establish R&D process equipment as well as production equipment for new projects
• Practically work closely with the product developer
• Being part of the idea evaluation process of new projects
• Being part of the production optimization team
• Coordinating and participating in the drafting of procedures, protocols, reports
• Providing regular updates to R&D management, as needed, on: Progress in the above areas (updated budgets, timetables, and other)

REQUIREMENTS:

• Key is the mix of practical and theoretical skills together with theoretical interest
• B.Sc. or M.Sc. required within the field mechanical design or automation
• Minimum of 4 years of aggregate experience working in the medical device industries
• Knowledge of and experience with regulations and guidelines pertaining to the medical device industry, including ISO 13485, CFR 820 and Medical Device Directive
• Experience of the following areas are plus:
– Polyurethane and its use within Medical Device
– Processes such polymer spraying and coating
– Other production methods including polymer and Nitinol
– Purchasing of equipment and external services
• Excellent interpersonal and communication skills as well as leadership
• 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-509851