Senior Software Quality Engineer – Medical Devices

Outset Medical, Inc.; San Jose (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Outset Medical, Inc. is seeking a Senior Software Quality Engineer to drive design assurance for medical device software from concept through production.

You will partner with Regulatory, R&D, Test, and Manufacturing to ensure robust software quality, cybersecurity, and risk management in compliance with FDA/ISO standards. You will lead SQA strategy, perform root cause analysis, and mentor teammates while supporting cross-functional initiatives to improve the Quality Management System and

Qualifications

• Bachelor's degree required in a technical field; Master's preferred.
• Minimum 5 years of hands-on Quality Engineering experience in medical devices.

Responsibilities

• Collaborate with Regulatory, R&D, Test and Manufacturing to promote Quality tools and design control methodologies.
• Support SQA strategy and execution plans.
• Apply IEC 62304 and ISO 13485/14971 requirements to development and sustaining engineering.
• Lead/root cause analysis for defects and ensure CAPA closure.
• Develop and execute system verification/validation plans and reports for software in medical devices.
• Mentor team members and foster a collaborative environment.

Skills

Quality Engineering

Regulatory compliance

Root cause analysis

Cross-functional collaboration

Documentation

Auditing

Risk management

Education

Bachelor's degree in Computer or Engineering Science, Electrical or Software Engineering (or similar)

Tools

Statistical analysis software

Job description

Outset Medical, Inc. is seeking a Senior Software Quality Engineer to drive design assurance for medical device software from concept through production.

You will partner with Regulatory, R&D, Test, and Manufacturing to ensure robust software quality, cybersecurity, and risk management in compliance with FDA/ISO standards. You will lead SQA strategy, perform root cause analysis, and mentor teammates while supporting cross-functional initiatives to improve the Quality Management System and