Software Validation Quality Engineering Lead
4 weeks ago
At Intuitive Surgical, we are dedicated to advancing the world of minimally invasive care. Our mission is to empower healthcare professionals to deliver life-enhancing care through innovative technology and intelligent design.
We are a pioneer and market leader in robotic-assisted surgery, and we strive to foster an inclusive and diverse team that is committed to making a difference. Our team members are passionate about their work and are driven by a shared vision to improve patient outcomes.
Job SummaryWe are seeking a highly skilled Software Validation Quality Engineering Lead to join our team. As a key member of our Digital and Data Products team, you will be responsible for overseeing the validation of our GxP regulated computerized systems, ensuring compliance with regulatory requirements and industry standards.
You will lead the development and approval of validation documentation, risk assessments, and impact assessments of proposed changes to computerized systems. You will also perform and direct GxP computerized system validation projects in compliance with 21 CFR 820, ISO 13485, ISO 62304, 21 CFR Part 11, and Annex 11.
Key Responsibilities- 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.
- Education: Degree in software Biomedical engineering or equivalent technical discipline.
- 8+ years' hands-on experience in Software Design/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.
Intuitive Surgical is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information, or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Shift: Day
Travel: None
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