Senior Design Quality Engineer

As a Senior Design Quality Engineer, you will develop, implement, and maintain technical quality assurance and control systems and activities. This position will define and specify the implementation of standards, methods, and procedures for inspecting, testing, and evaluating the precision, accuracy, and reliability of company products. You will participate in the review of engineering designs to contribute to quality requirements and considerations. 

This position will work with quality assurance to develop processes, test procedures, and implement systems that ensure the products and processes fulfill quality standards, meet safety regulations, and satisfy expectations.

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

• Assist in 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–complex robotic medical device.
• Lead in design quality activities, for product development starting from the requirements phase through development, V&V, and design transfer to commercialization phase activities.
• Participate with input and maintenance of the Design History Files (DHF) for each product family.
• Assist in the implementation of post-market surveillance reviews and preparation of clinical evaluation report data.
• Responsible for QMS process and product compliance with FDA and ISO 13485 such as Production and Process Controls, Complaints, CAPA investigations, and data analysis.
• Create and/or approve Document Change Orders.
• Other duties as assigned.

About You

• Minimum of a BS in Engineering or equivalent degree.
• 6+ years of related experience, preferably in complex electro-mechanical medical devices.
• Good 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 Equipment collateral standards, and IEC 62366 Usability Engineering of Medical Devices.

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.