Principal Mechanical Engineer

Medical Device Mechanical / Systems Engineering Leader  

Are you an industry seasoned, systems oriented mechanical engineer with significant experience developing surgical instruments and/or navigation tools for orthopedics?  If you are and seek a significant career opportunity with a growing medical device company, this could be an ideal opportunity for you. Our client has created groundbreaking 3D imaging systems that use Augmented Reality to superimpose virtual surgical guides and implants on the actual operating site. 

The surgeon uses a transparent optical headset to view surgical pathways without looking away at a distant monitor and disrupting direct observation of the patient and the seamless flow of the procedure.  This “smart” system rapidly analyzes and navigates the surgical landscape in real time, and enabling optimum alignment and accurate placement of instruments and implants. The uses the device in conjunction with traditional surgical loupes. The company’s spinal surgery system is FDA cleared, commercialized, and reimbursed. It can be used with minimally invasive, open, and next generation robotic surgery. Additional orthopedic applications are in development.

About the Role

This high level position reports to the VP of R&D. It requires considerable commercial medical device development experience and demonstrated initiative applying broad mechanical engineering skills on both the detailed design and systems level.  The seasoned, highly skilled Mechanical Engineer in this visible role will be responsible for leading the design, development, analysis and refinement of orthopedic surgical instruments with  mechanical and optical components, materials and processes, with consideration of systems level applications.

Responsibilities

Lead and personally contribute to the design, development, and refinement of metal orthopedic surgical instruments and applications from R&D to manufacturing transfer, using state-of-the-art materials, optical elements, mechanical design concepts, and design tools.

Provide leadership, mentoring and development of mechanical engineering staff.

Manage or conduct evaluation of designs and processes by analysis, modeling and experimentation.

Plan, perform or lead engineering and product V&V tests, studies, and experiments.

Perform technical evaluations of vendors designs, prototypes and manufacturing processes to ensure specifications and reliability.

Assist Contract Manufacturers in transfer of design projects from development to production.

Design and test processes for surgical cart refinement, performance and safety.

Support PMO with project planning and monitoring to ensure timely task completion.

Work cooperatively with RA/QA on validations for biocompatibility, cleaning, sterilization.

Prepare and document engineering reports and communicate results.

Qualifications

BS or MS in Mechanical or Optomechanical Engineering.

Ten plus years’ industrial experience developing medical devices, including at least five years creating surgical instruments, tools, implants, or imaging devices. 

Orthopedic device development experience is highly preferred. Exposure to opto-mechanic devices or imaging is a plus.

Successful experience as an engineering mentor and product development leader.

Proficiency using SolidWorks or equivalent, and DFMEA.

Working knowledge of applicable FDA, IEC, and ISO regulations and standards.

Experience with sterility and packaging.

Exposure to advanced manufacturing processes.

Ability and comfort working in a dynamic start-up environment, collaborating with cross-functional internal and external development teams, and Contract Manufacturers.