Senior Quality Engineer - Ion (Design Controls / Risk Based Software)

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:

Intuitive Surgical designs and manufactures highly complex surgical systems including cameras, instruments, and accessories for use in surgery. We are looking for a strong quality functional leader to support the projects associated with the development of next generation products.

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.

Roles & Responsibilities:

• 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

Skills, Experience, Education, & Training:

• Requires a minimum of 8 years of related experience with a University Degree (in Computer science, software engineering, biomedical engineering, or 5 years of relevant experience and an Advanced Degree (in electrical, mechanical or system engineering, math, or physics)  
• Expertise in medical device standards such as IEC 62304, ISO 80002-1, ISO 14971, IEC 60601, ISO 42001, ISO/IEC 27001, and FDA Design Controls; and/or comparable standards from a highly-regulated industry.
• Experience with risk-based software validation, software test automation, and SDLC processes.
• Preferred experience in AI/ML-based medical software (SaMD/embedded AI).
• Knowledge of cybersecurity and data pri