The Mullings Group - Raleigh, NC

posted about 1 month ago

Full-time - Senior
Remote - Raleigh, 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.
  • Ensure compliance with FDA guidelines, particularly regarding sterility standards for medical devices.
  • Utilize CAD software and PDM/PLM systems for design drafting and refinement.
  • Conduct simulations and analyses, including kinematic, stress, thermal, and vibration assessments.
  • 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.
  • Communicate design choices and challenges effectively to stakeholders.
  • 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 in Mechanical or Biomedical Engineering with 8+ years of experience, or MS with 6+ years of experience in mechanical or biomedical engineering, specifically in Class II or III medical devices.
  • Experience with robotic systems and manipulator design, particularly in forward/inverse kinematics and state estimation.
  • Deep understanding of mechanism design and electronic systems packaging.
  • Experience with Quality Management Systems and managing design documentation.
  • High proficiency in CAD software, preferably Solidworks.
  • Experience in performing kinematic, stress, thermal, and vibration analysis using simulation tools or hand calculations.
  • Hands-on experience in prototyping, debugging, and testing mechanical systems.
  • Knowledge of design for manufacturing, including GD&T considerations.
  • Understanding of failure modes and conducting risk analyses.

Nice-to-haves

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

Benefits

  • Flexible work-from-home options
  • Opportunities for professional development
  • Collaborative work environment
  • Impactful role in medical device innovation
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