Site Research & Development Manager Jena Occlutech is the leader in developing innovative products for the treatment of structural heart disease. The Company manufactures, develops, sells and markets Class III medical devices for the transcatheter repair of structural heart defects, including a range of specialized devices for patients with atrial fibrillation or heart failure, in over 90 markets around the world. Occlutech operates facilities in Germany, Turkey and Sweden. For additional information please visit our website at .
Reports to: CEO Jena
Occlutech's Site R&D Managers are expected to closely collaborate with each other and to work hand in hand with Occlutech's Executive Management Team to formulate company-wide R&D strategies and roadmaps to innovation. Each Site R&D Manager is expected to structure, manage and direct their respective teams located at Occlutech's R&D centers in Germany (Jena) and Turkey (Istanbul), respectively and to assure cross-departmental collaboration as needed to meet Occlutech's local and global R&D plans and objectives. In addition, Site R&D managers are responsible for product focused research, the development of new products, and to assure compliance with the latest ISO, MDSAP, MDR, 21CFR820, or applicable standards. Together with Occlutech's Executive Management Team Site R&D Managers are accountable for organizing and conducting ideation activities, to generate disruptive innovation, and to drive new product development that will build demand. Moderate travel required.
- Compiling, maintaining and managing detailed plans, budgets and outlining specific steps necessary for the successful execution of R&D plans and tasks with agreed-upon dates and resources needed to complete each milestone.
- Planning, preparing and conducting ideation activities.
- Attracting and retaining the very highest caliber of R&D engineers and advancing engineering & scientific talent
- Providing technical leadership and maintain Occlutech design control, change control and risk management processes to facilitate diligence in the engineering process and compliance to industry expectations.
- Collaborating closely with all functional areas necessary to aggressively advance products from proof-of-concept through validation and product launch, including Regulatory, Quality, Clinical & Marketing
- Has a minimum of 10 years of broad R&D experience with experience in the medical device industry with a proven track-record of successfully directing the efforts of diverse technical teams
- Has strong analytical skills and an advanced technical degree from a top tier university (M.Sc.degree in biomedical, or mechanical engineering a minimum)
- Is an effective team builder and problem solver, exhibiting a collaborative management style and the ability to bring out the best in people through example
- Is comfortable leading the execution of all aspects of research and product development including prioritization of projects, and the design, verification and validation of disposables, as well as capital equipment and software
- Has strong technical and business mind and is able to visualize future strategy while also outlining and driving tactics to complete the milestones to successfully execute that strategy.
- Has good working knowledge of ISO 13485, MDSAP & 21 CFR 820 quality system and work experience with nitinol or other, shape-memory materials a must.
- Is an excellent communicator who radiates compassion, integrity and loyalty to Occlutech and its respective customers, partners, shareholders, and employees.
- Fluency in written and spoken English a must.