The Mullings Group - Charlotte, NC

posted about 1 month ago

Full-time - Senior
Remote - Charlotte, NC
Professional, Scientific, and Technical Services

About the position

The Senior Mechanical Design Engineer will play a crucial role in developing mechanical systems for a next-generation kinematic surgical navigation system aimed at improving orthopedic procedures. This position involves leading the design and development of advanced kinematic systems, ensuring compliance with medical device regulations, and collaborating with multidisciplinary teams to integrate mechanical, electrical, and software components effectively.

Responsibilities

  • Lead the design and development of advanced kinematic systems, focusing on manipulator design and kinematics.
  • Apply a deep understanding of mechanism design to ensure efficient packaging of electronic subsystems.
  • Ensure all designs comply with FDA guidelines, particularly regarding sterility standards.
  • Utilize CAD software and PDM/PLM systems to draft and refine designs in a controlled manner.
  • Conduct simulations and analyses, including kinematic, stress, thermal, and vibration, to validate designs.
  • Engage in hands-on prototyping, debugging, and testing of electro-mechanical systems.
  • Optimize designs for manufacturing, considering relevant processes and GD&T.
  • Use programming skills in Python, MATLAB, and/or C/C++ for testing and data analysis.
  • Manage design control documentation related to mechanical hardware design.
  • Evaluate potential failure modes and conduct DFMEA to mitigate risks.
  • Collaborate with multidisciplinary design teams to ensure seamless integration of systems.
  • Maintain high standards of excellence and professionalism in a fast-paced environment.
  • Communicate effectively with stakeholders regarding design choices and challenges.
  • Apply principles of thermal management and isolation in design.
  • Participate in human factors analysis during the design phase.
  • Develop and manage comprehensive test plans for validation and verification activities.

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 forward/inverse kinematics and state estimation.
  • Deep understanding of mechanism design and electronic systems packaging.
  • Experience operating within a Quality Management System and managing design documentation.
  • High proficiency with CAD software, preferably Solidworks.
  • Experience performing kinematic, stress, thermal, and vibration analysis using simulation tools 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.
  • Experience working in a multidisciplinary design team.

Nice-to-haves

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

Benefits

  • Flexible work-from-home options
  • Opportunity to work on innovative medical devices
  • Collaborative and multidisciplinary team environment
  • Professional development opportunities
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