Staff Software Quality Engineer

The role

The Staff Software Quality Engineer serves as a technical quality leader for software design assurance and lifecycle quality oversight. This person will partner with cross-functional teams to ensure medical device software is developed and maintained according to regulatory requirements.

What you will do

• Partner with cross-functional teams to ensure design controls are established and maintained.
• Provide design assurance guidance for software testing strategy and validation planning.
• Develop and execute Software Quality Assurance strategy and operational execution plans.
• Apply knowledge of medical device software and quality system standards.
• Engage with development teams to align automated testing techniques.
• Monitor customer feedback and report defects.
• Serve as primary quality representative for software, hardware, and system changes.
• Lead and contribute to safety and cybersecurity risk management.
• Support Design Verification and Validation planning and execution.
• Identify product quality and quality system improvement opportunities.

Required qualifications

• Bachelor’s degree in computer or engineering science, Electrical or Software Engineering (or similar)
• Minimum of 7 years of hands-on experience in Design Assurance / Quality Engineering discipline
• Prior experience in the medical device field
• Ability to work effectively in a fast paced and dynamic environment
• Strong leadership, collaboration, and influencing skills
• Strong written and verbal communication skills
• Thorough knowledge of FDA Quality System requirements, ISO 13485:2016, ISO 14971, ANSI/ AAMI SW96, and Good Manufacturing Practices (GMP)

Nice to have

• Master’s degree
• Experience with Capital Equipment medical devices with embedded software and/or digital health initiatives
• Certified Software Quality Engineer, Certified Quality Engineer, or equivalent certification
• Lead Auditor Certification
• Lean certification
• Experience with statistical analysis methods or statistical analysis software
• Self-starter with demonstrated ability to lead initiatives
• Demonstrated ability to deliver best-practice outcomes and continuous improvement
• Excellent interpersonal skills

About the company

Outset is a medical device company revolutionizing the field of dialysis through groundbreaking technology. The company focuses on reducing the cost and complexity of dialysis care.