Design Engineer II

2 days ago

Irvine, CA, United States Kasmo Global Full time
Job Title: Design Engineer II
Duration: 1+ Year Contract

Job Description

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.

Responsibilities
  • 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).
Requirements
  • 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 SolidWorks, 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.
Preferred Skills
  • 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.

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