Senior Software Quality Engineer – Medical Devices

Regulatory Jobs; San Jose (CA); On-site; USD 155,000 - 209,000; Full time

Job summary

Outset Medical is seeking a Staff Software Quality Engineer to lead software design assurance, quality strategy, and lifecycle quality oversight for medical device software and connected health solutions.

You will partner with Software R&D, Test, Systems Engineering, Manufacturing, Regulatory, Product Management, Human Factors, Cybersecurity, and Quality to ensure products are developed, verified, validated, released, and maintained to FDA/ISO standards.

Qualifications

• Bachelor’s degree in computer or engineering science (or similar) required.
• 7+ years in design assurance/quality engineering.
• Experience in medical device field, preferably with embedded software.
• Strong leadership and collaboration skills.
• Knowledge of FDA QSR/ISO 13485/14971 and related standards."

Responsibilities

• Establish and maintain design controls across software projects.
• Provide guidance on testing strategy, verification, and validation.
• Develop and execute SQA strategy and plans.
• Lead risk management activities and cybersecurity considerations.
• Mentor team members and serve as quality representative on projects.
• Ensure compliance with FDA regulations and ISO standards.

Skills

Software quality

Regulatory knowledge

Leadership

Risk management

Communication

Education

Bachelor's degree in computer/engineering

Master's degree preferred

Job description

Outset Medical is seeking a Staff Software Quality Engineer to lead software design assurance, quality strategy, and lifecycle quality oversight for medical device software and connected health solutions.

You will partner with Software R&D, Test, Systems Engineering, Manufacturing, Regulatory, Product Management, Human Factors, Cybersecurity, and Quality to ensure products are developed, verified, validated, released, and maintained to FDA/ISO standards.