Staff Software Quality Engineer

Outset Medical, Inc.; San Jose (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Outset Medical, Inc. seeks a Staff Software Quality Engineer to lead software quality efforts for medical device software and digital health solutions.

You will partner with software engineering, test, regulatory, and quality teams to ensure design controls, verification and validation, and lifecycle quality across products, with strong emphasis on regulatory alignment. The role requires hands-on experience in design assurance, risk management, and cross-functional leadership within a fast-paced

Qualifications

• Bachelor's degree in engineering or computer science required; Master’s preferred.
• Minimum 7 years of hands-on design assurance/quality engineering in medical devices.

Responsibilities

• Establish and maintain design controls with cross-functional teams.
• Lead software quality assurance strategy, verification and validation planning.
• Ensure compliance with FDA QSR, ISO 13485, ISO 14971 and IEC 62304.
• Mentor team members and serve as quality representative for hardware/projects.
• Identify quality improvements and drive CAPA investigations and resolutions.

Skills

Design assurance

Regulatory knowledge

Software testing strategy

Risk management

Leadership

Cross-functional collaboration

Education

Bachelor's degree in engineering

Master's degree preferred

Tools

CAPA system

Risk management tools

Job description

The Staff Software Quality Engineer serves as a technical quality leader responsible for software design assurance, software quality strategy, and lifecycle quality oversight for medical device software and connected/digital health solutions. This role partners closely with Software Engineering, Test, Systems Engineering, Manufacturing, Regulatory Affairs, Product Management, Human Factors, Cybersecurity, and Quality teams to ensure software products are developed, verified, validated, released, and maintained in accordance with applicable regulatory requirements, consensus standards, and internal quality system procedures.

The incumbent supports one or more projects across the software development lifecycle, from concept development through commercialization and sustaining engineering. This person must be versatile to support other design assurance activities such as data analysis, problem solving/ failure analysis, full QMS compliance and alignment with the software development practices, Business Process Optimization initiatives and continuous improvement to the Quality Management System. The Staff Software Quality Engineer also provides technical leadership, mentors other team members, and may serve as the Quality representative for hardware, system, or manufacturing-related projects when needed.

Duties And Responsibilities

• Partner with Regulatory Affairs, Software R&D, Test, Systems Engineering, Manufacturing, and other cross-functional teams to ensure appropriate design controls are established, implemented, maintained, and objectively evidenced.
• Provide design assurance guidance for software testing strategy, test method development, verification planning, validation planning, protocol/report expectations, and objective evidence requirements.
• Develop and execute Software Quality Assurance (SQA) strategy and operational execution plans.
• Apply working knowledge of applicable medical device software and quality system standards, including FDA Quality System requirements, ISO 13485, ISO 14971, IEC 62304, IEC 62366, AAMI SW96, and applicable cybersecurity guidance, as appropriate to assigned products and projects.
• Engage with the development team to align best practices and techniques for automated unit and integration testing.
• Continuously monitor customer feedback and report defects found through defect tracking system, provide necessary information to reproduce the defect to arrive at a solution.
• Serve as primary quality representative on one or more teams and projects for software, hardware, and system changes.
• Lead / Contribute to all elements of safety and cybersecurity risk management. Assesses risk by facilitating the development of risk management tools and contributes to the completion of the overall product risk management file.
• Support Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities. Develop and execute system related verification and validation plans and protocols, and test reports for medical and non-medical device software.
• Identify product quality and quality system improvement opportunities and drive procedure updates when required.
• Support departmental effort in CAPA investigation and completion.
• Collect, analyze, trend, and communicate quality data throughout the organization for proper escalation and applicable resolution.
• Ensure compliance with applicable U.S. Food and Drug Administration regulations, other applicable regulatory requirements, company policies, procedures, processes, and assigned tasks.
• Develop and maintain strong relationships with internal and external stakeholders
• Provide technical leadership and mentoring to Quality Engineering team members and cross-functional partners.
• Serve as subject matter expert in internal and external audits
• Support additional activities, as assigned

Requirements/Qualifications

• Bachelor’s degree in computer or engineering science, Electrical or Software Engineering (or similar)is required. Master’s degree preferred. Previous experience in the role can be considered.
• Minimum of 7 years of hands-on experience in Design Assurance / Quality Engineering discipline. Previous experience in the role can be considered.
• Prior experience in the medical device field is required; preferably experience with Capital Equipment medical devices with embedded software and/or digital health initiatives is required.
• Ability to work effectively in a fast paced and dynamic environment.
• Strong leadership, collaboration, and influencing skills, with the ability to guide teams through risk-based decision-making in a regulated environment.
• Strong written and verbal communication skills.
• Thorough knowledge of FDA Quality System requirements, ISO 13485:2016 (Quality System) requirements, ISO 14971 (Risk Management) requirements, ANSI/ AAMI SW96, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
• Strong written and verbal communication skills.

Desired Qualifications:

• Certified Software Quality Engineer, Certified Quality Engineer, or equivalent certification preferred.
• Experience with statistical analysis methods or statistical analysis software preferred.
• Self-starter with demonstrated ability to lead initiatives, influence teams, and drive results with limited supervision.
• Demonstrated ability to deliver best-practice outcomes, added value, and continuous improvement across the business and quality management system.
• Excellent interpersonal skills and ability to build strong working relationships with internal departments, contractors, suppliers, and external stakeholders.