Senior Quality Engineer - Software/Firmware

Socket.dev; Sunnyvale (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Intuitive Surgical in Sunnyvale, CA is seeking a Senior Quality Engineer to support the full software lifecycle for medical devices, from concept to commercialization. You will guide compliance with ISO and FDA standards, participate in design reviews, and ensure robust software verification and validation.

The role requires experience in regulatory quality systems, risk management, and cross-functional collaboration with R&D, manufacturing, and regulatory affairs to deliver safe, high-impact

Qualifications

• Experience with medical device standards and regulatory frameworks.
• Proven expertise in SDLC processes and risk-based software validation.
• Ability to lead cross-functional teams and communicate with executives.

Responsibilities

• Software quality assurance & compliance activities to ISO 13485, FDA 21 CFR Part 820, IEC 62304, ISO 14971, and MDR.
• Lead risk management activities and collaborate with R&D and testing teams.
• Support design history file, design inputs/outputs, and traceability matrices.
• Provide regulatory support with submissions and audits.
• Drive process improvement and test automation strategies across teams.

Skills

IEC 62304

ISO 80002-1

ISO 14971

IEC 60601

FDA Design Controls

SDLC

Risk management

Software validation

Data modeling

Cross-functional collaboration

Education

University degree in CS/Software/Biomedical/Systems/Engineering/Math/Physics

Advanced degree in relevant field

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.

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 8years of related experience with a University Degree (in computer science, software/biomedical/systems/electrical/mechanical engineering, math or physics) or 5years 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).
• Knowledge of cybersecurity and data privacy (IEC 81001-5-1, ISO 27001, NIST, GDPR, HIPAA).

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 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.

Mandatory Notices

U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

This position may be filled at a different job level than listed here depending onbusiness need and/or on the selected candidate’s experience, knowledge and skills.Compensation will be based primarily on the job level at which the role is filled and thecandidate’s qualifications, consistent with applicable law.

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. The target compensation ranges are listed.

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.