Hybrid : Remote Sr. Mechanical Design Engineer : Robotics / Kinematics / Mechanisms

The Mullings Group - San Jose, CA

Full-time - Senior

San Jose, 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 enhancing 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 comprehensive system modeling, all while ensuring compliance with FDA guidelines and optimizing designs for manufacturing.

Responsibilities

• Lead the design and development of advanced kinematic systems, focusing on manipulator design, kinematics (both forward and inverse), state estimation, and comprehensive 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 design requirements specific to medical devices.
• 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 manufacturing processes, GD&T, and other production considerations.
• Use basic programming skills in Python, MATLAB, and/or C/C++ to run tests, gather data, and analyze performance of electro-mechanical hardware systems.
• Manage all design control documentation related to mechanical hardware design.
• Evaluate potential failure modes of designs and conduct Design Failure Mode and Effects Analysis (DFMEA) to identify and mitigate potential risks.
• Collaborate closely with multidisciplinary design teams to ensure seamless integration of electrical, mechanical, and software systems.
• Maintain a high standard of excellence and professionalism in a high-paced role.
• Communicate effectively with stakeholders regarding design choices and challenges, working well both as part of a team and autonomously.
• Understand and 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 developing clinical workflows that align with the electro-mechanical system's capabilities.
• Develop and manage comprehensive test plans related to validation/verification activities and quantify system performance for FDA submission.

Requirements

• BS and 8+ years of experience or MS and 6+ years of experience in mechanical, biomedical engineering, or equivalent (Class II or III medical device experience required).
• Experience with robotic systems and manipulator design, especially 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 required documentation related to mechanical design.
• High proficiency with CAD software (Solidworks preferred).
• 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, especially with consideration of relevant manufacturing processes and GD&T.
• Sound understanding of failure modes and conducting various risk analyses to determine and mitigate potential risks.
• Experience working as a member of a multidisciplinary design team, ensuring integration of electrical, mechanical, and software systems.
• Excellent track record in a high pace, high impact role.
• Excellent communication skills and ability to thrive in a team as well as autonomously.

Nice-to-haves

• Experience with thermal management and thermal isolation, especially as it relates to sterile reprocessing and extreme temperature exposure of sensitive electronic devices.
• Basic programming ability in Python, MATLAB, and/or C/C++ to test and analyze performance of hardware systems.
• Understanding of human factors analysis as it relates to system setup, sterility, and clinical workflow development.

Benefits

• Flexible work arrangements (Hybrid/Remote)
• Opportunities for professional development
• Collaborative work environment
• Impactful work in the medical device field