Design Engineer II

Design Engineer II

We are seeking a skilled Design Engineer II to join our team in Irvine, CA. This role requires a hands-on mechanical engineer with experience in new product development, especially within the medical device industry. The ideal candidate will have a strong background in catheter design, mechanical design, and the application of core engineering principles in real-world product development scenarios.

• Independently apply engineering principles to analyze and troubleshoot complex systems.
• Select and apply appropriate techniques to solve technical issues across projects.
• Summarize, analyze, and draw insights from advanced test results.
• Design, coordinate, and execute engineering tests and experiments.
• Evaluate feasibility and reliability of new products and test methods.
• Manage tasks independently with minimal oversight, providing design direction as needed.
• Apply deep understanding of customer requirements to influence design decisions.
• Provide guidance or mentorship to entry-level engineers and technicians.
• Ensure compliance with design control processes as part of Product Realization (Quality Manual).
• Contribute to the creation and maintenance of DHF, DMR, and other R&D deliverables in PLM systems.
• Work with vendors and identify new partners for component or system development.
• Utilize engineering techniques in areas including fluid mechanics, heat transfer, FEA/CFD, and medical device design standards (e.g., Design of Experiments, regulatory compliance).

• Bachelor's or Master's degree in Mechanical Engineering or a related field.
• 3–6 years of relevant industry experience (preferably in medical device development).
• Proficiency with Solid Works, mechanical design, and engineering documentation.
• Proven experience in new product development and catheter design.
• Strong understanding of core mechanical engineering principles.
• Familiarity with regulatory standards and design controls in the medical device industry.

• Experience with FEA/CFD or other simulation tools.
• Familiarity with PLM systems for document control (e.g., Agile, Windchill).
• Understanding of IP strategy, test method development, and verification/validation procedures.