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Staff Design Quality Engineer

Vicarious Surgical

Vicarious Surgical

Design, Quality Assurance
Waltham, MA, USA
Posted on Friday, June 28, 2024

Vicarious Surgical is hiring a seasoned and passionate Staff Design Quality Engineer to join our groundbreaking team. You will play a pivotal role to develop, implement, and maintain technical quality assurance and control systems and activities.

As a Staff Design Quality Engineer, you will define and specify the implementation of standards, methods, and procedures for inspecting, testing, and evaluating precision, accuracy, and reliability of our medical surgical robotic system. You will participate in the reviewing of engineering designs to contribute to quality requirements and considerations and assist product support areas in gathering and analyzing data. This role will ensure the safety, efficacy, and reliability of our surgical robotic system upholds the highest standards of quality throughout the entire product development lifecycle.

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.

This is a terrific opportunity for a Staff Design Quality Engineer in the medical device industry to join our company at a very exciting time and be a key member of a team of mission-driven and kind individuals with diverse experiences to lead Vicarious into market disruption.

Key Responsibilities

  • Responsible for Design Controls and Risk Management processes for a complex robotic medical device.
  • Author and 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.
  • Review and support product requirements, test documentation, and design reviews.
  • Participate or lead determination of sampling plans for product and process testing (engineering and V&V testing).
  • Provide guidance on statistical techniques and their application to product and process testing.
  • Author and maintain product and process-related quality records.
  • 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.
  • Other duties as assigned.

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 21 CFR PART 820, 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.
  • Able to create and execute training for team members on quality processes and systems.

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.