Senior Engineer I, Research and Development - FEA

Job Title: Senior Engineer, Research and Development - FEA

• Senior Engineer I, Research and Development - FEA
• Senior Engineer II, Research and Development - FEA
• Senior Engineer III, Research and Development - FEA

Role Level: Individual Contributor

Supervisor/Manager Title: Director, Research and Development, Valves

Job Location & Environment: Irvine, CA – Corporate Office Environment, R&D Lab

Job Description Summary: Responsible for supporting the development of subsystems and components for transcatheter heart valve and delivery system using Finite Element Analysis (FEA) and test method development.

Job Responsibilities:

• Develop and validate test methods for components (nitinol, viscoelastic material like porcine pericardium etc.) or subsystems for transcatheter heart valves and delivery systems in accordance with quality system requirements.
• Develop and validate FEA models for components (nitinol, viscoelastic material like porcine pericardium etc.) 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 of 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.

Required Education and Experience:

• A Bachelor of Science degree in Mechanical or Biomedical Engineering (or equivalent engineering degree) is required.
• Minimum of 5+ years’ experience in R&D or product development of medical devices, pharmaceutical or life sciences product technology. Level I, II, III DOE.
• Minimum of 3 years of experience in FEA is required.
• Minimum of 3 years of experience with Abaqus and/or equivalent software is required.
• Knowledge of the product development process and applicable Quality System requirements in the medical device industry is required.

Skills and Abilities Required for This Job:

• 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 be able to conduct hands-on work.
• Must be able to handle multiple tasks with high attention to detail.

Physical Requirements:

• Ability to sit or stand for extended periods while working at a computer or in meetings.
• Ability to work in a laboratory and/or manufacturing environment, including wearing appropriate PPE.
• Ability to move between office, lab, and manufacturing floor environments as needed.