Full-Time
Senior Software Quality Engineer
Confirmed live in the last 24 hours
Robotic system for minimally invasive surgery
Senior, Expert
Waltham, MA, USA
- 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.
- 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.
Vicarious Surgical Inc. specializes in developing advanced robotic systems specifically designed for minimally invasive abdominal surgery. The company stands out for its state-of-the-art technology which promotes smaller surgical incisions, enhanced precision, and superior control of surgical instruments, potentially leading to improved patient outcomes. This focus on cutting-edge surgical innovation and commitment to improving surgical processes make it an excellent place for professionals passionate about advancing medical technology and patient care.
Company Stage
IPO
Total Funding
$345.3M
Headquarters
Waltham, Massachusetts
Founded
2014