Sr Software Quality Engineer

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

Primary Function of Position

This position will report into Senior Manager - Software Quality Engineering. The primary responsibility of this person is to represent PQ as a self-directed quality oversight on the GxP Computerized Systems Validation efforts globally across Intuitive sites around the world.

Essential Job Duties

• Maintains responsibilities for ensuring GxP computerized systems, including SaMD/SiMD, AI-enabled platforms, and IT digital systems, operate within the framework of regulations (GxP, 21 CFR Part 11/820, EU MDR), applicable Quality Modules, IEC 62304, ISO 14971, and requirements defined in local/global procedures.
• Provide direct oversight for software lifecycle activities and computer system validation (CSV) from a quality assurance perspective to ensure compliance with SDLC, risk management, AI lifecycle controls, cybersecurity, and documentation rigor.
• Provide guidance on CSV, software assurance, and IEC 62304 validation issues and discrepancies. Support investigations of software-related defects, deviations, and CAPAs, including root cause analysis aligned with ISO and FDA expectations.
• Review CSV and software validation activities, including deliverables (traceability matrices, test protocols, risk analyses) from a regulatory compliance and quality standpoint, ensuring end-to-end lifecycle integrity.
• Provide support to internal and external audits, including health authority inspections, related to SaMD/SiMD, AI-enabled systems, and computerized system validation activities, ensuring readiness and documentation traceability.
• Advise cross-functional teams-R&D, IT, Regulatory, and QA-in an efficient and collaborative manner, demonstrating proven communication and time management skills to achieve quality milestones across complex project timelines.
• Help establish and sustain global computer system validation and software quality policies and standards incorporating industry best practices, GAMP 5 guidance, and health authority compliance requirements for both traditional and AI-based systems.
• Partner with internal software development teams, AI/ML engineers, cybersecurity, and external suppliers/vendors to ensure alignment of software quality expectations, algorithm transparency, and lifecycle compliance in AI-powered digital health systems.
• Solid knowledge of industry standards related to regulated software and Electronic Records/Electronic Signatures, including 21 CFR Part 11, Part 820, Annex 11, GAMP 5, IEC 62304, ISO 14971, and emerging AI regulatory frameworks (e.g., EU AI Act, FDA AI/ML guidance).
• Ensure alignment of validation and quality assurance processes, procedures, and methods across multiple product lines, business units, and global functions, including IT and engineering.
• Ensure SaMD/SiMD systems and AI-enabled tools are implemented in accordance with regulatory requirements and fully integrated with enterprise quality systems (e.g., QMS, LMS, eDMS, eQMS).
• Author and/or revise standard operating procedures (SOPs), work instructions, and templates related to software quality engineering, AI function deployment, SDLC, and CSV activities.
• Ability to provide expert guidance on validation document and protocol revisions, including test scripts, design documentation, AI model traceability, training data documentation, and verification strategies.
• Administer and support applicable electronic systems used for quality and compliance purposes (e.g., ALM, Jira, AI governance platforms, eQMS systems like Veeva or TrackWise).
• Assist as needed in audits and inspections, including preparing documentation, supporting interviews, and addressing audit findings for SaMD/SiMD, AI-enabled systems, and digital platforms.
• Interact with senior internal personnel and external partners on critical software quality and compliance matters, including AI functionality validation, requiring coordination across multiple global facility locations and teams.
• Contribute to projects focused on CSV and SDLC process improvements, digital transformation, and increasing validation efficiency through automation, AI-driven quality tools, and Agile/DevOps alignment.
• Support the Compliance team on computerized system and AI system audits, ensuring vendor qualification, algorithm lifecycle oversight, and supplier management programs are effectively maintained for software and AI/ML service providers.

Qualifications

Required Skills and Experience

• 6-8 years' experience in the Medical Device/FDA-regulated industry, with 3-5 years in Software Quality Engineering, Quality Assurance, or Software Compliance roles.
• Bachelor's or higher degree in Computer Science, Software Engineering, Informatics, Biomedical Engineering, or related fields (advanced degrees preferred).
• Comprehensive knowledge of computer system validation (CSV) and regulatory requirements, including 21 CFR Part 11, GMP, and GAMP guidelines.
• Expertise in medical device software standards such as IEC 62304, ISO 14971, IEC 60601, and FDA Design Controls.
• Proven experience working on embedded software (SiMD) and Software as a Medical Device (SaMD), including development, verification, and validation.
• Strong proficiency in design control processes, including generating, reviewing, and approving documentation throughout the SDLC, such as DHF deliverables, SRS, SAD, SDS, V&V, traceability, risk management/FMEA, and cybersecurity.
• Maintain knowledge of the evolving regulatory landscape for Digital Health, Artificial Intelligence, and Machine Learning technologies, incorporating best practices into SDLC processes and QMS.
• Experience with risk management, including conducting risk assessments, software risk analysis, and FMEA in medical device software development.
• Knowledge of cybersecurity assessments and risk mitigation as part of software quality management.
• Familiarity with Agile/Scrum methodologies and SDLC tools like JIRA, DOORS, and Jama for requirements management and issue tracking.
• Hands-on experience validating ERP systems (e.g., SAP), SaaS platforms, and COTS applications in compliance with regulatory standards.
• Proven ability to support compliance to various QMS procedures and activities, including risk management, internal and external audits, change control, and training.
• Proven ability to collaborate with cross-functional teams (e.g., R&D, software engineering, IT) and represent the Quality Engineering function in technical and management reviews.
• Strong experience supporting internal and external audits to meet compliance with software quality and regulatory standards.
• Excellent communication, negotiation, and interpersonal skills, with advanced problem-solving and decision-making abilities.
• Results-driven with exceptional attention to detail, organizational skills, and a commitment to quality and customer focus.

Additional Information

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

Intuitive 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.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications . click apply for full job details