Sr. Mechanical Design Engineer
Surgical Navigation : Medical Device
Robotic/Mechatronic Mechanisms
Hybrid / Remote : Northern Ohio / 3 Hour Radius
Manipulator design : Kinematics (Inverse/Forward)
State Estimation : Dynamic System Modeling
Our client is developing a surgical navigation tool to enable and aid surgeons in the accurate placement of implants in orthopedic procedures.
This proprietary 3D navigation system is designed to improve the accurate placement of implants and reduce complications rates. Our system converts free-hand procedures to guided procedures leading to improved implant placement, reduced complications, and reduced OR time.
In orthopedic surgery, many procedures like hip fractures and ACL reconstructions are performed free-hand guided by 2D imaging that creates inconsistent implant placement which can lead to complications.
As the Senior Mechanical Design Engineer, you will be responsible for developing mechanical systems solutions for our next generation kinematic surgical navigation system.
This person wil lead the mechanical design and development of advanced kinematic systems, specifically focusing on manipulator design, kinematics (both forward and inverse), state estimation, and comprehensive system modeling.
Responsibilities:
o Lead the design and development of advanced kinematic systems, specifically focusing on manipulator design, kinematics (both forward and inverse), state estimation, and comprehensive system modeling.
o Apply a deep understanding of mechanism design, ensuring efficient packaging of electronic subsystems within the manipulator's mechanical structure.
o Ensure all designs are compliant with FDA guidelines, particularly focusing on sterility standards and other design requirements specific to medical devices.
o Utilize CAD software, coupled with the associated PDM/PLM systems, to draft
and refine designs in a revision controlled manner.
o Conduct a range of simulations and analyses, including kinematic, stress,
thermal, and vibration, using both simulation tools and hand calculations to
validate designs.
o Engage in hands-on prototyping, debugging, and testing of electro-mechanical
systems, iterating designs based on the results.
o Ensure designs are optimized for manufacturing, keeping in mind relevant
manufacturing processes, GD&T, and other production considerations.
o Use basic programming skills in Python, MATLAB, and/or C/C++ to run tests,
gather data, and analyze the performance of the electro-mechanical hardware
systems.
o Manage all design control documentation as it relates to mechanical
hardware design.
o Evaluate potential failure modes of the designs and conduct Design Failure
Mode and Effects Analysis (DFMEA) to identify and mitigate potential risks.
o Collaborate closely with multidisciplinary design teams, ensuring that electrical, mechanical, and software systems are integrated seamlessly to achieve desired outcomes.
o Maintain a high standard of excellence and professionalism, operating efficiently in a high-paced and impactful role.
o Communicate effectively, both in articulating design choices and challenges to stakeholders, and work well both as part of a team and autonomously.
o Understand and apply principles of thermal management and thermal
isolation, especially in the context of sterile reprocessing and exposure of
electronic devices to extreme temperatures.
o 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.
o Develop and manage comprehensive test plans related to
validation/verification activities and quantify system performance, ensuring data is organized and prepared for FDA submission and evaluation.
Qualifications and Education:
o 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)
o Experience with robotic systems and manipulator design, especially
forward/inverse kinematics, state estimation, and system modeling
o Deep understanding of mechanism design and packaging of electronic
systems
o Experience operating within a Quality Management System and managing
required documentation as it relates to the mechanical design of a system
o High proficiency with CAD software (Solidworks preferred)
o Experience with performing kinematic, stress, thermal, and vibration analysis
using simulation tools and/or hand calculations
o Hands-on prototyping, debugging, and testing experience
o Experience with design for manufacturing, especially with consideration of
relevant manufacturing processes and GD&T
o Sound understanding of failure modes and conducting various risk analyses
to determine and mitigate potential risks
o Experience working as a member of a multidisciplinary design team, where
electrical, mechanical, and software systems must work together to
accomplish a desired outcome
o Excellent track record and the ability to work in a high pace, high impact role o Excellent communication skills and ability to thrive in a team as well as
autonomously.
Preferred Qualifications
o Experience with thermal management and thermal isolation especially as it
relates to sterile reprocessing and extreme temperature exposure of sensitive
electronic devices
o Basic programming ability in Python, MATLAB, and/or C/C++ to test and
analyze performance of hardware systems
o Understanding of human factors analysis as it relates to system setup,
sterility, and clinical workflow development
