R&D Catheter Engineer II
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.
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.