Software Validation Quality Engineering Lead

As Intuitive’s da Vinci® Surgical System continues to be adopted by an increasing population of hospitals, surgeons and patients, we are expanding our product offering to support a more comprehensive robotic program for our customers. As a part of this expansion this individual will support projects that fall within a new and growing team- Digital and data products.

As a part of this expansion, we are looking for an ideal candidate to possesses a broad base of experience and a high level of technical depth in individual who will be assigned to work on digital and data software non-medical products**.** As part of the role, you will work in a highly skilled, multi-disciplinary team who you will coach, mentor, teach and influence in best software Quality practices.

This is not a Software testing role.

Roles and Responsibilities:

• Responsible for oversight of all GxP regulated computerized systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements
• Provide oversight of validation activities, lead the development and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated and conduct impact assessment of proposed changed to computerized systems
• Perform and/or direct GxP computerized system validation projects in compliance with 21 CFR 820, ISO 13485, ISO 62304, 21 CFR Part 11, Annex 11 and Data Integrity
• Ensure that GxP systems meet intended uses and comply with applicable regulations, current industry practices, and Intuitive Surgical policies and procedures
• Support systems and new product introduction by serving as a Quality resource, providing expertise, problem solving, and strategies for problem prevention
• Participate as the Product Quality representative in project team activities and process design to ensure cGxP compliance and interdepartmental consistency within the validation program
• Assure compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements as related to validation
• Coordinate and provide training and/or opportunities for career development of others
• Drive a culture of continuous improvement by employing Practical Process Improvement concepts and reporting metrics and communicating internally to diverse audiences
• Serve as local focal point: act as mentor for the local team in India, assist with prioritization and assignments of tasks and report on progress to the global team

Requirements

• Education: Degree in software Biomedical engineering or equivalent technical discipline
• 8+ years’ hands on experience in SoftwareDesign/ Quality Engineering in a medical device/ Pharma industry with a focus on GxP system
• Experience in a lead role/ managing a team is preferred
• Hands-on experience with agile scrum process and tools (Agile/JIRA/Atlassian/Polarion).
• Hands-on experience with Software Validation following 21 CFR Part 11, ISO 62304, and applicable medical device QMS & software Life Cycle process.
• Working knowledge of 21 CFR 820, ISO 13485, ISO 14971, 21 CFR Part 11, GAMP5, electronic record and electronic signature.
• Experience working on low and high-risk software applications using a scalable approach to the SDLC practices and the QMS.
• Ability to work in a geographically diverse business environment.
• Attention to details and Quality are critical to success.
• Excellent organizational, interpersonal, and verbal and written communication skills, with the ability to deliver quality outputs under minimum supervision.