Teams at JenaValve Technology

Use FEA (Abaqus) and test method development to design, validate, and document components and subsystems for transcatheter heart valves and delivery systems. Develop assembly and manufacturing procedures, partner with Quality and Manufacturing on risk analysis and verification, procure components, and transfer designs to external manufacturers following medical device quality system requirements.

Provide hands-on manufacturing engineering support for THV production: troubleshoot equipment, optimize processes using lean principles, create work instructions and training, perform data analysis and CAPA/root cause investigations, lead process improvements, support equipment/fixture design, and execute process characterization and validation to ensure quality and regulatory compliance.

Lead cross-functional teams to plan, execute, and launch heart valves, delivery catheters, and related components. Manage schedules, budgets, risks, regulatory compliance (FDA/ISO), quality systems, stakeholder communications, and technical requirements throughout product development and commercialization.