Senior Engineer I, Research and Development

JenaValve Technology, Inc.; Irvine (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

JenaValve Technology, Inc. seeks a Senior Engineer in Research and Development to contribute to the development of subsystems and components for transcatheter heart valves and delivery systems.

You will design and document components, procure parts, develop assembly procedures, and work with Quality and Manufacturing to ensure proper fit, function, and transfer to external manufacturers. Leadership of Technicians and cross-functional collaboration are essential.

Qualifications

• Bachelor of Science in Mechanical or Biomedical Engineering required.
• 3-5+ years in Research & Development required; DOE levels I–III.
• Knowledge of medical device product development and Quality System requirements.
• Ability to work effectively in cross-functional teams.
• Strong written and verbal communication of results.
• Strong documentation skills.
• Hands-on approach and initiative.
• Ability to manage multiple tasks with attention to detail.

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 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.
• Supervise Technicians.

Skills

Cross-functional teamwork

Effective communication

Documentation

Hands-on

Attention to detail

Initiative

Education

B.S. in Mechanical or Biomedical Engineering

Job description

Job Title: Senior Engineer, Research and Development

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

Job Description Summary: Responsible for the development of subsystems and components for transcatheter heart valves and delivery systems

Job 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 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.
• Supervise Technicians.

Qualifications

Required Education and Experience:

• 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. Level I, II, III DOE.
• 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.

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 have the ability to conduct hands-on work.
• Must possess the ability to handle tasks with high attention to detail.