Senior (Quality Engineer 4) - Software/Firmware

Intuitive; Sunnyvale (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Intuitive in Sunnyvale seeks a Senior Quality Engineer to support software development from concept through commercialization for our medical devices.

You will guide software quality processes, risk management, design controls, and V&V, ensuring alignment with ISO 13485, FDA 21 CFR Part 820, IEC 62304, ISO 14971 and MDR. Collaboration with R&D and regulatory teams is essential.

Qualifications

• Experience with ISO 13485 and FDA 21 CFR Part 820.
• Familiarity with IEC 62304, ISO 14971 and MDR.
• Knowledge of software lifecycle and quality processes.
• Ability to work with cross-functional teams on risk and verification.
• Experience with design history file and traceability.

Responsibilities

• Develop, implement, and maintain software quality processes per standards.
• Participate in design reviews, code reviews, defect tracking, and V&V activities.
• Ensure SDLC adherence including Agile practices.
• Support risk management per ISO 14971 and related standards.
• Collaborate with R&D, manufacturing, regulatory, and testing teams.

Skills

Software Quality Assurance

Risk Management

Regulatory Knowledge

Design Control

SDLC

Agile Methodologies

Job description

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.