Staff Design Quality Engineer

As our Staff Design Quality Engineer you will manage and direct the work of a design team throughout a project, from conception to finish. Projects usually have to do with designing systems, processes, and other components for various purposes. 

Working from our Waltham, MA headquarters, you will develop, implement, and maintain technical quality assurance and control systems and activities. You will also define and specify the implementation of standards, methods, and procedures for inspecting, testing, and evaluating the precision, accuracy, and reliability of company products and participate in the reviewing of engineering designs to contribute to quality requirements and considerations. 

Vicarious Surgical is a next generation robotics company developing a disruptive technology with the goal of increasing the efficiency of surgical procedure, improving patient outcomes and reducing healthcare costs.

Key Responsibilities

• Responsible for Design Controls and Risk Management processes for a complex robotic medical device
• 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 products per ISO 14971 and IEC 62366-1
• Lead design quality activities, for product development starting from requirements phase through development, V&V, design transfer to commercialization phase activities
• Participate or lead with input and maintenance of the Design History Files (DHF) for each product family
• Participate in regulatory activities, including FDA 510(K) and tech file creation and submissions and Notified Body assessments
• Provide input to updates of the company’s Quality Management System procedures, instructions, forms and records to meet regulatory requirements
• Create or review Document Change Orders

About You

• Bachelor's Degree in Engineering or another technical discipline or equivalent experience/ quality certifications
• 8+ 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 ISO 14971:2019 Application of Risk Management, IEC 60601-1 Medical Electrical 

Together, we share a love for learning and we are passionate teachers.  As a company, we set ambitious goals and individually, we share in that ambition. At the office, we enjoy each other’s company during monthly social, catered lunches and company celebrations.

Please note that at Vicarious Surgical, we follow COVID-19 safety protocol, which may include compliance with vaccination, testing and masking requirements.