TUSTIN, CA  –  IRVINE, CA

Primary Job Function

Responsible for providing engineering support in the creation and development of new medical device products (Catheters & Guidewires).

Core Job Responsibilities

• Researches, develops, designs and evaluates mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment.
• Conducts feasibility studies to verify capability and functionality.
• Develops new concepts from initial design to market release.
• Directs support personnel and coordinates project activities.
• Write and submit intellectual property (patents).
• Maintains detailed documentation throughout all phases of research and development.
• Investigates and evaluates existing technologies.
• Reviews or coordinates vendor activities to support development.
• Understanding of design control activities.
• Conducts Installation, Operational and Performance Qualifications.
• Familiar with joining methods used to join materials in medical devices.
• Strong statistical background. Understanding of DOEs, process capability and data distributions.
• Ability to use SolidWorks and Minitab.

Requirements:

Bachelors of Science degree (BS) in relevant engineering, and 2 – 4+ years of regulated medical device work experience working with catheters, guide wires or similar devices. Advanced degree preferred.

Must be willing to authorize a background check.