Responsibilities:
Design and development of invasive medical products, sub-assemblies, components and manufacturing process according to clinical
specifications and regulatory requirements. From concept to production line implementation
Prepare detailed drawings, specifications and work-instructions
Perform as a subject matter expert in the fields of engineering calculation, material selection, manufacturing technologies, CAD and testing
designs
Generate technical reports and regulatory documents.
Verify the functionality of products design by developing test methodology and specifications to ensure that products design meet applicable
performance requirements
Design, execute, analyze & document tests: verification in-lab jigs and Ex-vivo validations
Design and implement device improvements & modifications
Interfaces with outside vendors for component selection, manufacturing, and assembly
Must-have Education, Experience and Skills:
BSc.in Mechanical Engineering
Work in accordance with the quality policy and quality objective and in compliance to applicable regulations and quality standards.
Minimum of 5 years’ experience in invasive medical products .
Ability to communicate in written and verbal English
Experience with design for plastic injection molding
Experience with additive manufacturing, 3D printing and rapid prototyping
Advantage Qualifications:
Experience as a design engineer in the Cardiovascular – Structural Heart field (procedures & delivery systems) – high advantage
Experience with R&D of class III medical device – advantage
Experience with design of transcatheter delivery systems – advantage
Experience with Nitinol design and manufacturing – advantage
Personal Competencies:
Team player, promotes cooperation and commitment to the team to achieve goals, but also able to work independently
Hands-On attitude, passion for creation
Strong interpersonal skills and the ability to establish and maintain effective working relationships, effectively work with cross functional teams in a multinational matrix organization.