Principal Mechanical Systems Engineer - Surgical Instruments
Principal Mechanical Systems Engineer - Surgical Instruments
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$ 170000 - 225000
1 Vacancy
Job Description
Are you a seasoned mechanical engineer with leadership experience developing surgical instruments implants or navigation tools If so and youre motivated to join a growing company employing advanced technology that improves outcomes youll 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 companys 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 The position 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 leading the design development analysis and refinement of mechanical components of metal surgical instruments materials and processes including consideration of their effects on the entire system. The position reports directly to the VP of R&D.
Responsibilities
- Lead and personally contribute to the design development and refinement of metal surgical instruments and their application using stateofthe 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.
- Lead 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 606011 and 12 ISO 109931 and 13485 standards and regulations for medical devices.
- Flexibility and comfort working in a dynamic startup environment.
- Proven effectiveness working with crossfunctional R&D teams and Contract Manufacturers.
- Effective written verbal interpersonal communication and presentation skills.
Location: Boston MASS. Northwest Boston area inside the I495.
Compensation: Base salary $170200K. Additional Bonus. Stock incentives.
Required Experience:
Staff IC
Employment Type
Full-Time
