Teams at JenaValve Technology

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.

Design and develop components and subsystems for transcatheter heart valves and delivery systems. Create and review drawings/specifications, develop test methods, conduct analyses and verification testing, partner with Quality and Manufacturing, perform vendor evaluation and failure analysis, and supervise R&D technicians.