Responsibilities:
• Design and development of Cardiovascular 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
• Participate as R&D representative in pre-clinical animal studies
Must-have Education, Experience and Skills:
• BSc.in Mechanical Engineering (or equivalent)
• Minimum of 5 years’ experience in class II medical device R&D
• Extensive knowledge in preforming complex calculations, GD&T, tolerance analysis, final elements analysis
• Experience and deep understanding of working under relevant regulations and standards: FDA QSR, ISO-13485, MDD (MDR)
• Ability to communicate in written and verbal English
• Experience with design for plastic injection molding
• Experience with additive manufacturing, 3D printing and rapid prototyping
• Experience as a design engineer in the Cardiovascular – Structural Heart field (procedures & delivery systems) – high advantage
• MSc. in Mechanical Engineering (or equivalent) – advantage
• Experience with R&D of class III medical device – advantage
• Experience with design of transcatheter delivery systems – 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
• Reliability and ownership, leading and mentoring Jr. level designers