Catheter Engineer

Catheter Engineer

Tustin - US

What we value:

• Honesty & Integrity: Uphold ethical standards and a strong work ethic.
• Passion & Curiosity: Show enthusiasm for medical device engineering and continuous learning.
• Problem Solving & Learning Ability: Demonstrate problem-solving skills and seek professional growth.

Key responsibilities:

• Develop, verify, and validate requirements/specifications for medical devices.
• Design and conduct lab experiments for design and test method development, performing statistically driven data analysis.
• Conduct feasibility studies to assess components, subassemblies, and complete medical devices.
• Develop new concepts from initial design to market release and support fielded products.
• Collaborate with Quality, Regulatory, Manufacturing, and Supplier Development teams.
• Support process development alongside manufacturing engineers.
• Lead project planning, R&D activities, and manage support personnel.
• Analyze and generate intellectual property (patents).
• Maintain detailed documentation throughout R&D phases.
• Investigate and evaluate existing technologies.

What we are looking for:

• Bachelor's degree (BS) in Mechanical Engineering with 5+ years of experience, or a Master's degree (MS) in a relevant engineering field with 3+ years of medical device R&D experience.
• Minimum 3 years of experience in medical devices with a focus on electrophysiology, including a strong understanding of EP procedures, technologies, and materials.
• Strong mechanical engineering knowledge, including mechanics of materials, thermodynamics, failure analysis, and CAD.
• Experience with design controls in a regulated environment and statistically driven analysis.
• Knowledgeable in electrophysiology, catheter design, and development.

What we offer:

• Impactful work in the medical device industry.
• Collaborative environment and career development.
• Comprehensive benefits, including medical, dental, vision, 401(k), PTO, and disability support.