Principal Design Quality Engineer

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Vicarious Surgical is hiring a Senior Design Quality Engineer to join our Quality, Regulatory and Clinical team in Waltham, MA. 

Vicarious Surgical’s novel approach to surgery uses a combination of proprietary, human-like surgical robots and virtual reality to transport surgeons inside the patient when performing minimally invasive surgery. Our technology was granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA), which provides unique opportunities for our regulatory pathway.  

This is a terrific opportunity for an experienced design quality engineering professional to join our company at a very exciting time and be a key member of a team that will bring our robotic solution to the market, offering a cost-effective path to improving patient outcomes and increasing the efficiency of surgical procedures for hospitals.

Responsibilities:

  • Responsible for Design Controls and Risk Management processes for a complex robotic medical device.
  • Assist in or lead the establishment of the Risk Management File and Usability Engineering related activities (FMEAs, Hazard Analysis, Risk Plans, Reports) for new product development and commercially released product per ISO 14971 and IEC 62366-1
  • Assist in or lead design quality activities, for product development starting from requirements phase through development, V&V, design transfer to commercialization phase activities
  • Participation with input and maintenance of the Design History Files (DHF) for each product family
  • Participate on teams to; create, update or manage the master verification & validation plans, cross-matrices, protocols and reports
  • Assist in the implementation of post market surveillance reviews and preparation of clinical evaluation report data
  • Mentor engineering teams on areas such as: designed experiments, hypothesis testing, problem solving techniques, process mapping, cause and effect diagrams, experimentation, risk analysis, mitigation, quality function deployment, mean time between failure analysis, measurement systems analysis, sample creation and selection, statistical techniques, gage R&R studies, inspection techniques, etc.
  • Participate in regulatory activities, including FDA 510(K) and tech file creation and submissions and Notified Body assessments
  • Create and/or update the company’s Quality Management System procedures, instructions, forms and records to meet regulatory requirements
  • Prepare and/or approve Document Change Orders

About You

  • Bachelor's Degree in Engineering or another technical discipline, or equivalent experience/ quality certifications.
  • 7+ years of related experience, including working with a complex electro-mechanical medical device
  • Strong understanding of ISO 13485, FDA 21CFR PART820, EU Medical Device Regulations 
  • Experience with of ISO 14971:2019 Application of Risk Management, IEC 60601-1 Medical Electrical Equipment collateral standards and IEC 62366 Usability Engineering of Medical Devices
  • Experience or strong desire and capabilities to work in a start-up medical device company that includes a fast-paced development environment
  • Working experience in full-lifecycle engineering programs and processes
  • Structured medical device product development experience in requirements-driven engineering, documentation, rigorous verification, etc
  • Able to clearly identify, define, and communicate technical, process, and quality related issues or improvements with internal and external personnel 
  • Strong skills in word processing, spreadsheet, presentation, manufacturing and database software
  • Demonstrated skills in managing priorities and coordinating team activities while supporting and executing cross-functional team decisions; mentoring capabilities and people management skills are helpful
  • Able to create and execute training for team members on quality processes and systems
More Information on Vicarious Surgical
Vicarious Surgical operates in the Hardware industry. The company is located in Waltham, MA. Vicarious Surgical was founded in 2014. It has 220 total employees. It offers perks and benefits such as Open door policy, OKR operational model, Team based strategic planning, Open office floor plan, Flexible work schedule and Mandated unconscious bias training. To see all 1 open jobs at Vicarious Surgical, click here.
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