About the position
As a Senior Design Quality Engineer, you will define and support the development of the Vicarious Surgical medical surgical robotic system. You will provide quality and compliance input to the project team for project decisions and product development deliverables (e.g. Design & Development Plan, User Needs, Design Input Requirements, Test Methods, Design Review, Design V&V, Usability Testing, Packaging and Labeling). This role will ensure the safety, efficacy, and reliability of our surgical robotic system while upholding the highest standards of quality throughout the entire product development lifecycle. This position will interact with key functions including R D, Project Management, Supply Chain, and Manufacturing. 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.
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).
- Support and lead biocompatibility testing and sterilization validation.
- 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 updating 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.
Requirements
- BS in Mechanical, Electrical, or Biomedical Engineering.
- 6+ years of medical device Design Quality experience, including working with a complex electro-mechanical medical device.
- Detailed understanding and working knowledge of US and International regulations including 21 CFR, 820, Medical Device Directive, EN ISO 13485, EN ISO 14971, IEC 60601-1 Medical Electrical Equipment collateral standards, IEC 62304 Medical Device Software life cycle processes, and IEC 62366 Usability Engineering of Medical Devices.
- Experience in biocompatibility testing and sterilization validation.
- Experience with process validation (IQ/OQ/PQ).
- Knowledge of software development lifecycle (SDLC), software verification and validation processes, and software risk management in a regulated environment.
- Strong communication and presentation skills.
- Competent with use of Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).
