Senior Quality Engineer - Software/Firmware

Intuitive; Sunnyvale (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Intuitive in Sunnyvale is seeking a Senior Quality Engineer to support product development from concept through commercialization. You will serve as a core member of the cross-functional software team, guiding software development lifecycle, design controls, risk management, and V&V activities to ensure compliant, reliable medical device software.

The role emphasizes enforcing ISO 13485 and FDA standards, collaborating with R&D, testing, regulatory affairs, and manufacturing, and driving

Qualifications

• Experience implementing software quality processes per ISO 13485, FDA 21 CFR Part 820, IEC 62304, ISO 14971, MDR.

Responsibilities

• Develop, implement, and maintain software quality processes in compliance with standards.
• Participate in design reviews, code reviews, defect tracking and software validation activities.
• Ensure adherence to SDLC processes, including Agile methodologies.

Skills

ISO 13485

SDLC & Agile

Risk management

Design controls

Regulatory submissions

Test automation

Cross-functional collaboration

Software validation

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.