Senior SQA Engineer - Medical Device Software

Regulatory Jobs; San Jose (CA); On-site; USD 136,000 - 184,000; Full time

Job summary

Outset Medical is seeking a Senior Software Quality Engineer to drive design assurance for medical device software from concept through production. You will collaborate with Regulatory, R&D, and Manufacturing to ensure compliance with FDA QSR, ISO13485, ISO14971, and ISO62304, while mentoring teams in good quality practices.

The role involves risk management, verification/validation planning, and cross-functional problem solving to deliver safe, reliable software across hardware and disposables.

Qualifications

• Bachelor's degree in Computer or Engineering Science (or similar) required; Master’s preferred.
• Minimum of 5 years hands-on experience in Quality Engineering in the medical device field.
• Experience with FDA Quality System Regulations, ISO 13485:2016, ISO 14971, ANSI/AAMI SW96 and GMP requirements.

Responsibilities

• Collaborate with Regulatory, R&D, Test and Manufacturing to apply Design Control methodologies.
• Support Software Quality Assurance strategy and execution plans.
• Lead or contribute to risk management and safety/cybersecurity activities.
• Develop and execute verification and validation plans and test reports for medical device software.

Skills

Quality engineering

Regulatory knowledge

Software QA

Leadership

Education

Bachelor's in Engineering or related

Tools

Statistical software

Quality management software

ISO 62304 knowledge

Job description

Outset Medical is seeking a Senior Software Quality Engineer to drive design assurance for medical device software from concept through production. You will collaborate with Regulatory, R&D, and Manufacturing to ensure compliance with FDA QSR, ISO13485, ISO14971, and ISO62304, while mentoring teams in good quality practices.

The role involves risk management, verification/validation planning, and cross-functional problem solving to deliver safe, reliable software across hardware and disposables.