Senior Quality Engineer - Software/Firmware

Company Description

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.

We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.

If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.

Job Description

Primary Function of Position
The Senior Quality Engineer supports product development from concept through commercialization and serves as a core team member of the cross-functional software development team. This role provides expertise and guidance on software development lifecycle, design controls, risk management, anomaly tracking and code reviews. Additionally, the position ensures the compliance, reliability, and safety of software used in our medical devices.

Essential Job Duties

• Software Quality Assurance & Compliance

  • Develop, implement, and maintain software quality processes in compliance with ISO 13485, FDA 21 CFR Part 820, IEC 62304, ISO 14971, and MDR.

  • Participate in design reviews, code reviews, defect tracking and reviews, and software validation activities.

  • Ensure adherence to software development lifecycle (SDLC) processes, including Agile methodologies.

• Risk Management

  • Support risk management activities in accordance with ISO 14971, IEC 62304, and ISO 80002-1

  • Collaborate with R&D and testing teams to identify and mitigate software defects.

  • Ensure the completeness and full coverage of software verification and validation (V&V) protocols, including unit testing, integration testing, and system testing.

• Design Control

  • Participate in and support the development of the product design history file, ensuring compliance with internal processes and external standards and regulations.

  • Partner with engineering to define design inputs, design outputs, and traceability matrices.

• Regulatory Support:

  • Support Regulatory Affairs with creating submissions and responding to submission questions.

  • Support internal and external audits, including preparation and direct interaction with auditors.

• Process Improvement & Cross-Functional Collaboration

  • Drive continuous improvement in software quality processes and methodologies.

  • Work closely with software development, regulatory affairs, manufacturing, and post-market teams to ensure high-quality software delivery.

  • Implement test automation strategies to improve efficiency and coverage.

Qualifications

Required Skills and Experience

• Experience in medical device standards such as IEC 62304, ISO 80002-1, ISO 14971, IEC 60601, and FDA Design Controls.

• Experience with risk-based software validation, software test automation, and SDLC processes

• Expertise with data modeling and interpretation in areas like field product performance, log analysis, reliability modeling.

• Ability to navigate quality systems with minimal oversight on individual projects.

• Balanced risk decision-making to drive product quality, gain consensus, and work through technical challenges.

• Ability to solve complex problems with minimal oversight.

• Ability to articulate complex information to teams, including executive management

Required Education and Training

Requires a minimum of 8 years of related experience with a University Degree (in computer science, software/biomedical/systems/electrical/mechanical engineering, math or physics) or 5 years of relevant experience and an Advanced Degree (in above disciplines)

At least 2 years in a regulated industry is preferred

Preferred Skills and Experience 

• Preferred experience in AI/ML-based medical software (SaMD/embedded AI).