💼 About This Role

You'll perform design assurance activities for medical device software at Outset Medical, supporting software R&D and manufacturing. Your work will directly impact the Tablo Hemodialysis System, a first-of-its-kind dialysis technology. This role offers the chance to shape quality practices in a trailblazing medical device company.

🎯 What You'll Do

• Support Software Quality Assurance strategy and operational execution plans.
• Lead risk management activities including safety and cybersecurity risk evaluation.
• Develop and execute system verification and validation plans and protocols.
• Collect, analyze, and communicate quality data for escalation and resolution.

📋 Requirements

• Bachelor's degree in Computer or Engineering Science, Electrical or Software Engineering.
• 5+ years hands-on experience in Quality Engineering discipline.
• Prior experience in medical device field with capital equipment and embedded software.
• Thorough knowledge of FDA Quality System requirements and ISO 13485:2016.

✨ Nice to Have

• Master's degree preferred.
• Knowledge of ISO 14971 and ANSI/AAMI SW96.
• Experience with automated unit and integration testing best practices.

📨 Hiring Process

Estimated timeline: 3-5 weeks · AI estimate

1. 1Recruiter phone screen· 30 min
2. 2Technical interview with team· 1 hour
3. 3Onsite interviews· 3-4 hours