As a Senior Software Quality Engineer, you will be a subject matter expert of compliance related to the development lifecycle and maintenance processes of product software and software development tools and validation and maintenance of non-product software. You will be responsible for quality system support for software R&D projects; generation and/or review of software quality documentation; providing inputs to software R&D designs; assisting with the development of verification and validation strategies and improving quality processes for product software systems.
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
- Maintain software development life cycle and maintenance processes.
- Partner with the SW Development Team and support the verification and validation processes to ensure accurate and reliable performance of the medical device software according to documented requirements.
- Manage the disposition of defects, enhancements, and customer feedback utilizing software tracking tools.
- Participate and/or lead Software risk management activities throughout the product development life cycle.
- Participate with the SW Development Team in software requirements and user story definition, and in reviews to ensure an appropriate level of rigor and testability.
- Participate in internal and external software-related portions of audits as a subject matter expert; monitor and audit the software quality processes for compliance, effectiveness, continued alignment with applicable regulatory and statutory requirements, and opportunities for improvement.
- Maintain the non-product software validation process by developing and executing validation plans, functional and user requirement specifications, IQ/OQ/PQ protocols, and validation reports.
- Assist and guide internal system owners in the validation of non-product software validations.
- Other duties as assigned.
About You
- Minimum of a BS in Engineering, Computer Science, or related discipline.
- 6+ years of related experience, including 4+ years working in a highly regulated environment; software related role supporting quality, new product development, or manufacturing.
- Knowledge of medical device product development lifecycle, including design controls, risk management, software configuration, design verification, and validation preferred.
- Strong working knowledge of IEC 62304, ISO 13485, FDA 21CFR PART820, FDA 21CFR Part 11, ISO 14971, and related medical device regulations.
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.
