Senior Engineer I, Research and Development

About the role

Responsible for the development of subsystems and components for transcatheter heart valves and delivery systems.

Responsibilities

• Develop components or subsystems for transcatheter heart valves and delivery systems in accordance with quality system requirements.
• Design and document components and subsystems.
• Procure components.
• Develop assembly procedures.
• Conduct engineering analysis and feasibility testing of components and subsystems to ensure proper fit and function.
• Partner with Quality to conduct risk analysis and develop and execute design verification activities.
• Partner with Manufacturing to develop manufacturing procedures and processes and transfer the product to external manufacturing houses.
• Supervise Technicians.

Qualifications

• A Bachelor of Science degree in Mechanical or Biomedical Engineering (or equivalent engineering degree) is required.
• Minimum of 3-5+ years of experience in Research & Development is required.
• Knowledge of the product development process and applicable Quality System requirements in the medical device industry is required.
• Must be able to work effectively and collaborate within cross functional teams.
• Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel.
• Must have strong documentation skills.
• Must take initiative and have the ability to conduct hands-on work.
• Must possess the ability to handle multiple tasks with high attention to detail.