Senior Engineer I, Research and Development

Jenavalve Technology; Irvine (CA); On-site; USD 86,000 - 116,000; Full time

Job summary

Jenavalve Technology in Irvine, CA is seeking a Senior Engineer, Research and Development to drive subsystems for transcatheter heart valves and delivery systems. You will design components, document subsystems, procure parts, and supervise technicians while collaborating with Quality and Manufacturing under strict medical device quality systems.

The role requires a BS in Mechanical or Biomedical Engineering and 3–5+ years of R&D experience; strong communication, hands-on initiative, and

Qualifications

• Bachelor's degree in Mechanical or Biomedical Engineering.
• 3–5+ years of R&D experience required.
• Knowledge of medical device product development and Quality System requirements.
• Ability to work effectively with cross-functional teams.
• Strong written and verbal communication skills.
• Solid documentation and traceability practices.
• Hands-on initiative and multitasking ability.

Responsibilities

• Develop components or subsystems for transcatheter heart valves and delivery systems per quality system.
• Design and document components and subsystems.
• Procure components as needed.
• Develop assembly procedures.
• Perform engineering analysis and feasibility testing for subsystems.
• Collaborate with Quality on risk analysis and design verification.
• Work with Manufacturing to establish procedures and transfer product to external manufacturers.
• Supervise Technicians.

Skills

Cross-functional collaboration

Written communication

Documentation

Hands-on engineering

Attention to detail

Education

Bachelor of Science in Mechanical or Biomedical Engineering

Job description

Job Details

Job Location: Irvine, CA 92618

Position Type: Full Time

Education Level: 4 Year Degree

Salary Range: $101,300.00 - $101,300.00 Salary

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.

QualificationsRequired 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.