R&D Engineer I, Heart Valve Systems

Jenavalve Technology

Irvine (CA)

On-site

USD 86,000 - 116,000

Full time

6 days ago

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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.