Vicarious Surgical is hiring a Software Quality Engineer to join our team in Waltham, MA. The Software Quality Engineer is a subject matter expert of compliance related to the verification, validation, and maintenance processes of non-product software.  The SW Quality Engineer will be responsible for validation strategies and improving quality processes for non-product software systems and applications used throughout the organization.

This key team member will play a key role in developing, executing, and maintaining computer system validation for applicable software programs which are used as execution of quality management system processes or critical business functions, in accordance with current applicable standards and regulations (including FDA 21 CFR Part 11, FDA General Principles of Software Validation and ISO 13485).

Vicarious Surgical’s novel approach to surgery uses a combination of proprietary, human-like surgical robots and virtual reality to transport surgeons inside the patient when performing minimally invasive surgery. Our technology was granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA), which provides unique opportunities for our regulatory pathway. 

This is a terrific opportunity for an experienced quality professional to join our company at a very exciting time and be a key member of a team that will bring our robotic solution to the market, offering a cost-effective path to improving patient outcomes and increasing the efficiency of surgical procedures for hospitals.

Responsibilities

• Manage and maintain non-product software validation processes which blend industry best practices and the needs of the company to ensure accurate and reliable performance of non-product software in accordance with the intended use of the software within the organization and current regulations.
• Develop, execute, and maintain validation plans; functional and user requirement specifications; Operational, Performance and Installation Qualifications; and associated reports for non-product software applications (such as eQMS, PLM, ERP systems, etc.) in accordance with current medical device national and international regulations and standards.
• Develop validation maintenance plans using a risk-based approach for cloud-based, on-prem and software as a service (SaaS) applications which may include the use of automated testing tools to keep application in a validated state
• Maintain a company-wide computer system inventory, working with IT and system owners to establish and maintain necessary GxP assessments
• Maintain effective communication with cross-functional project teams on scope, requirements and intended use changes.
• Participate with software owners and IT in the software vendor selection process; defining and analyzing business, regulatory, and user requirements; identifying vendor candidates; developing evaluation criteria, etc.
• Participate in internal and external non-product software related portions of audits; monitor and audit the non-product software quality processes for compliance, effectiveness, continued alignment with applicable regulatory and statutory requirements and opportunities for process improvements.
• Other duties as assigned

About You

• Minimum Bachelor’s degree in Computer Science, Information Science or related discipline
• 5+ years experience working in a highly regulated environment (Medical Device or Pharmaceutical Software Quality role is highly preferred).
• Implementation and validation of FDA 21 CFR Part 11 compliant systems
• Strong working knowledge of the FDA 21 CFR Part 11, General Principles of Software Validation (GPSV), ISO 13485, and related medical device regulations
• Ability to mentor junior team members
• Demonstrated desire to contribute in any way necessary to support the company goals and objectives
• Highest personal values and ethical standards