Senior Engineer I, Research and Development - FEA

JenaValve Technology, Inc.; Irvine (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

JenaValve Technology, Inc. in Irvine, CA is seeking a Senior Engineer, Research and Development - FEA to advance subsystems for transcatheter heart valves and the delivery system using finite element analysis and test method development.

You will develop and validate test methods for nitinol and viscoelastic materials, create FEA models with Abaqus, document designs, procure components, and help transfer manufacturing processes.

Qualifications

• :BS in Mechanical or Biomedical Engineering required.
• “5+ years in R&D or medical device product development”
• “3+ years of FEA experience”
• “3+ years with Abaqus or equivalent software”
• “Knowledge of medical device product development and QMS requirements”

Responsibilities

• Develop and validate test methods for components or subsystems for transcatheter heart valves and delivery systems in accordance with quality system requirements.
• Develop and validate FEA models for 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 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.

Skills

Cross-functional teamwork

Technical reporting

Documentation

Initiative

Multi-tasking

Education

Bachelor of Science in Mechanical or Biomedical Engineering

Tools

Abaqus

Job description

Job Title

Senior Engineer, Research and Development - FEA

Role Level

Individual Contributor

Supervisor/Manager Title

Director, Research and Development, Valves

Job Location & Environment

Irvine, CA 1 20e 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

Required Education and Experience:

• A Bachelor of Science degree in Mechanical or Biomedical Engineering (or equivalent engineering degree) is required.
• Minimum of 5+ years b9 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.