Senior Software Quality Engineer

The role

The Senior Software Quality Engineer performs design assurance activities for new and sustaining medical device software. This role supports the Software Development Lifecycle from concept through production by working with R&D, Test, and Manufacturing teams.

What you will do

• Work with Regulatory, R&D, Test and Manufacturing to ensure use of best practices and Design Control methodologies
• Support Software Quality Assurance strategy and operational execution plans
• Apply knowledge of IEC 62304 to product development and sustaining engineering projects
• Engage with development team to align automated unit and integration testing techniques
• Monitor customer feedback and report defects found through defect tracking system
• Serve as primary quality representative for software, hardware, disposables, and system changes
• Lead and contribute to safety and cybersecurity risk management
• Support Design Verification and Validation planning, execution, and root cause analysis
• Identify product quality and quality system improvement opportunities
• Support departmental effort in CAPA investigation and completion

Required qualifications

• Bachelor’s degree in Computer or Engineering Science, Electrical or Software Engineering (or similar)
• Minimum of 5 years of hands-on experience in the Quality Engineering discipline
• Prior experience in the medical device field
• 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
• A self-starter, motivated and able to positively motivate others
• Focused, target driven with a positive, can-do attitude
• Drive to assigned objectives which delivers best practice results, added value and continuous improvements
• Leadership and interpersonal skills to develop and manage good working relationships
• Certified Quality Engineer a plus
• Lead Auditor certification a plus
• Lean Certification a plus
• Experience with statistical analysis software a plus

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.