V&V Engineering Manager

Vicarious Surgical is hiring a V&V Engineering Manager to join our Systems Engineering team in Waltham, MA.  This key team member will bring broad based Systems Engineering experience to the role, with a particular emphasis on verification and validation processes and protocols, and will play a crucial part in establishing a formal V&V process for development of our novel surgical robot. 

This is a terrific opportunity for an experienced V&V engineering lead join our company at an 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. Specific responsibilities are listed below.

 Responsibilities

• Responsible for Overall System & Subsystem Level Design Verification strategy and planning
• Lead the V&V team who are responsible for verification and validation of the system
• Develop, and manage V&V engineers, provide technical guidance, evaluation, and facilitate career growth. 
• Create, review, and update of Verification and Validation Plans and Configuration Management Plans for Projects.
• Lead requirement workflows from requirements down to design output
• Work with Systems and Integration Engineering and other cross-disciplinary engineering functions to develop Test Cases,Protocols and documentation for design verification and validation  
• Lead the development  of verification and validation of test tools where required.
• Participate in FMEAs, Hazard/Harm Analysis, and other Risk Analysis activities per internal procedures and ISO 14971
• Determine Sample Size of verification tests using statistical risk-based methods
• Collaborate closely with Quality and Regulatory teams to deliver all required documentation
• Determine  sample size for testing using risk-based statistical methods.
• Participate in requirements review and developing acceptance test methods
• Report defects, tracking re-verification and closing. 
• Collaborate with Project management, which may include internal or external resources, developing and maintaining project schedules and budgets.

About You

• Minimum of a B.S. in Systems, Electrical, Biomedical or Mechanical Engineering.
• At least 10 years of medical device R&D / Engineering experience, including experience with verification and validation of complex electromechanical systems.
• Strong communication and leadership skills.
• Demonstrated success leading teams and fostering a collaborative / team-oriented approach to achieving objectives. 
• Experience leading and managing programs, handling resource planning, scheduling, budget maintenance, and risk-mitigation.
• Experience working with cross-functional team. 

Nice to Have  

• Experience developing V&V strategies for Robotic Systems.
• Experience working in Jama, Jira,  & Arena PLM.