The Mullings Group - Irvine, CA

posted about 2 months ago

Full-time - Senior
Irvine, CA
Professional, Scientific, and Technical Services

About the position

The Senior Mechanical Design Engineer will play a crucial role in developing a cutting-edge surgical navigation tool aimed at improving the accuracy of implant placements in orthopedic procedures. This position involves leading the design and development of advanced kinematic systems, focusing on manipulator design, kinematics, state estimation, and system modeling, all while ensuring compliance with medical device regulations.

Responsibilities

  • Lead the design and development of advanced kinematic systems, focusing on manipulator design, kinematics, state estimation, and system modeling.
  • Apply a deep understanding of mechanism design to ensure efficient packaging of electronic subsystems within the manipulator's mechanical structure.
  • Ensure all designs comply with FDA guidelines, particularly focusing on sterility standards and other medical device requirements.
  • Utilize CAD software and associated PDM/PLM systems to draft and refine designs in a revision-controlled manner.
  • Conduct simulations and analyses, including kinematic, stress, thermal, and vibration, using simulation tools and hand calculations to validate designs.
  • Engage in hands-on prototyping, debugging, and testing of electro-mechanical systems, iterating designs based on results.
  • Optimize designs for manufacturing, considering relevant processes, GD&T, and production considerations.
  • Use programming skills in Python, MATLAB, and/or C/C++ to run tests, gather data, and analyze performance of electro-mechanical systems.
  • Manage design control documentation related to mechanical hardware design.
  • Evaluate potential failure modes and conduct Design Failure Mode and Effects Analysis (DFMEA) to identify and mitigate risks.
  • Collaborate with multidisciplinary design teams to ensure seamless integration of electrical, mechanical, and software systems.
  • Maintain high standards of excellence and professionalism in a high-paced role.
  • Communicate effectively with stakeholders regarding design choices and challenges, working well both in teams and autonomously.
  • Apply principles of thermal management and thermal isolation in the context of sterile reprocessing and exposure of electronic devices to extreme temperatures.
  • Participate in human factors analysis during the design phase, focusing on system setup, sterility, and clinical workflows.

Requirements

  • BS and 8+ years of experience or MS and 6+ years of experience in mechanical or biomedical engineering, with Class II or III medical device experience required.
  • Experience with robotic systems and manipulator design, particularly in forward/inverse kinematics, state estimation, and system modeling.
  • Deep understanding of mechanism design and packaging of electronic systems.
  • Experience operating within a Quality Management System and managing documentation related to mechanical design.
  • High proficiency with CAD software, preferably Solidworks.
  • Experience performing kinematic, stress, thermal, and vibration analysis using simulation tools and/or hand calculations.
  • Hands-on prototyping, debugging, and testing experience.
  • Experience with design for manufacturing, considering relevant processes and GD&T.
  • Sound understanding of failure modes and conducting risk analyses to mitigate potential risks.
  • Experience working in a multidisciplinary design team where electrical, mechanical, and software systems must integrate.

Nice-to-haves

  • Experience with thermal management and thermal isolation related to sterile reprocessing and extreme temperature exposure of electronic devices.
  • Basic programming ability in Python, MATLAB, and/or C/C++ for testing and analyzing hardware performance.
  • Understanding of human factors analysis related to system setup, sterility, and clinical workflow development.
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