Are you a senior mechanical engineer or manager experienced developing surgical instruments, implants or navigation tools? If so and you’re motivated to join a growing company employing advanced technology that improves outcomes, you’ll want to explore this significant opportunity.
About the Company – Our client has created a groundbreaking Augmented Reality system that superimposes 3D virtual surgical guides and implants onto the actual operating site, which the surgeon views using a light weight, transparent optical headset. These surgical pathways are viewed without looking away at a monitor, which disrupts direct observation of the patient and seamless flow of the procedure. The system rapidly analyzes and navigates the surgical landscape in real time, enabling optimum alignment and accurate placement of instruments and implants, in conjunction with traditional surgical loupes. The company’s spinal surgery system is FDA cleared, commercialized, and reimbursed, and additional orthopedic applications in development. It can be used with minimally invasive, open, and next generation robotic surgery.
About the Role – This advanced level position reports to the VP of R&D. It requires considerable medical device industry experience and initiative applying broad mechanical engineering skills to both detailed and systems level design. The broadly skilled ME in this role will be responsible for the design, development, analysis and refinement of materials, processes and mechanical and optomechanical components of metal surgical instruments, including overall consideration of their effects on the entire system.
Responsibilities:
- Lead and personally contribute to the design, development and refinement of metal surgical instruments and their application, using state-of-the art materials, mechanical design concepts and tools, from R&D to manufacturing.
- Lead or conduct design and process evaluations with analysis, modeling and experiments.
- 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 the transfer of design projects from development into 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 engineering reports to document and communicate results.
- Mentor and develop engineering staff.
Qualifications:
- BS or MS in Mechanical or Optomechanical Engineering.
- Ten plus years’ experience developing medical devices, including at least five years creating metal instruments or implants, navigation components, or Augmented or Virtual Reality tools.
- Proficiency using SolidWorks or equivalent, and DFMEA
- Experience with sterility and packaging, and exposure to advanced manufacturing processes.
- Working knowledge of FDA, IEC 60601-1 and 1-2, ISO 10993-1 and 13485 standards and regulations for medical devices.
- Flexibility and comfort working in a dynamic start-up environment.
- Proven effectiveness working with cross-functional R&D teams and Contract Manufacturers.
- Effective written, verbal, interpersonal communication and presentation skills.