Senior Engineer I, Research and Development - FEA

Jenavalve Technology; Irvine (CA); On-site; USD 91,000 - 111,000; Full time

Job summary

Jenavalve Technology in Irvine, CA seeks a Senior Engineer in Research and Development (FEA) to support subsystems for transcatheter heart valves and delivery systems using FEA and test method development. This role requires a BS in Mechanical or Biomedical Engineering, 5+ years of R&D, and 3+ years of FEA with Abaqus.

You will develop and validate FEA models, design components, work with QA and manufacturing, and contribute to risk analysis and design verification activities in a regulated

Qualifications

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

Responsibilities

• Develop and validate test methods for components or subsystems for transcatheter heart valves and delivery systems.
• Develop and validate FEA models for components or subsystems for transcatheter heart valves and delivery systems.
• Design and document components and subsystems.
• Procure components.
• Develop assembly procedures.
• Conduct engineering analysis and feasibility testing of components of subsystems.
• 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.

Skills

Cross-functional collaboration

Technical communication

Documentation skills

Hands-on problem solving

Education

Bachelor of Science in Mechanical or Biomedical Engineering

Tools

Abaqus

FEA software

Job description

Job Details

Job DetailsJob Location: Irvine, CA 92618Position Type: Full TimeEducation Level: 4 Year DegreeSalary Range: $101,300.00 - $101,300.00 SalaryJob 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.

Qualifications

• 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.