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

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