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.
Skills Required
- Bachelor of Science in Mechanical or Biomedical Engineering (or equivalent)
- Minimum 5+ years experience in R&D or product development of medical devices, pharmaceutical or life sciences product technology
- Minimum 3 years experience in Finite Element Analysis (FEA)
- Minimum 3 years experience with Abaqus and/or equivalent FEA software
- Knowledge of product development process and applicable Quality System requirements in the medical device industry
- Ability to work effectively in cross-functional teams and strong verbal and written communication skills
- Strong documentation skills, initiative, hands-on capability, and ability to manage multiple tasks with attention to detail
What We Do
JenaValve Technology, Inc., with locations in Irvine, Calif., Leeds, U.K. and Munich, Germany, develops and manufactures transcatheter aortic valve replacement (TAVR) systems to treat patients suffering from aortic valve disease. The Company is in clinical development of its next-generation transfemoral TAVR system in both the U.S. and CE mark countries for treating patients with aortic stenosis and/or aortic regurgitation. In addition to Bain Capital Life Sciences, JenaValve is backed by European and Asian investors, including Andera Partners (formerly Edmond de Rothschild Investment Partners), Gimv (Euronext: GIMB), Legend Capital, NeoMed Management, RMM, Valiance Life Sciences and VI Partners. Additional information is available at www.jenavalve.com.
