Senior Software Quality Engineer

Regulatory Toolkit; San Jose (CA); On-site; USD 136,000 - 184,000; Full time

Job summary

Outset Medical is seeking a Senior Software Quality Engineer to drive design assurance for medical device software from concept through production. You will collaborate with Regulatory, R&D, and Manufacturing to ensure compliance with FDA QSR, ISO13485, ISO14971, and ISO62304, while mentoring teams in good quality practices.

The role involves risk management, verification/validation planning, and cross-functional problem solving to deliver safe, reliable software across hardware and disposables.

Qualifications

• Bachelor's degree in Computer or Engineering Science (or similar) required; Master’s preferred.
• Minimum of 5 years hands-on experience in Quality Engineering in the medical device field.
• Experience with FDA Quality System Regulations, ISO 13485:2016, ISO 14971, ANSI/AAMI SW96 and GMP requirements.

Responsibilities

• Collaborate with Regulatory, R&D, Test and Manufacturing to apply Design Control methodologies.
• Support Software Quality Assurance strategy and execution plans.
• Lead or contribute to risk management and safety/cybersecurity activities.
• Develop and execute verification and validation plans and test reports for medical device software.

Skills

Quality engineering

Regulatory knowledge

Software QA

Leadership

Education

Bachelor's in Engineering or related

Tools

Statistical software

Quality management software

ISO 62304 knowledge

Job description

Company Overview

Join us for an enriching journey with Outset, a trailblazing medical device company that is revolutionizing the field of dialysis. Our focus is to create one high performing team, obsessed with progress, in an atmosphere that is brimming with transformative opportunities. The heart of our mission is pioneering a groundbreaking technology that redefines the landscape of dialysis, streamlining complexity and cost, because patients deserve "better" now, not some day.

At Outset we're revolutionizing an industry and changing lives. We're impacting what the future of dialysis looks like by creating a first-of-its-kind technology in order to reduce the cost and complexity of dialysis. FDA cleared for use across care settings, from the hospital to the clinic to the home, the Tablo Hemodialysis System harnesses modern technology for a new holistic approach to dialysis care. We're giving providers time back to focus on patient care. And we're giving patients the power to take control of their life and get back to enjoying the things they love.

Position Overview:

The Senior Software Quality Engineer is responsible for performing design assurance activities for new introductions and sustaining of medical device software, with the purpose of supporting the Software R&D, Test and Manufacturing departments. The incumbent for this position will support the Software Development Lifecycle of one or more projects from concept generation through production. This person will work closely with software design, software testing, project management, product management, regulatory, human factors, and manufacturing teams to understand and influence the architecture, requirements, detail design, testing, safety and cybersecurity risk evaluation and deployment of the software designs to the market.

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. Additionally, this person must be able to perform as a Quality Assurance representative for hardware and disposable-related projects to support system-level reliability improvements when needed. They also help guide and mentor other team members in a collaborative environment.

Essential Job Functions and Responsibilities

• Work closely with Regulatory, R&D, Test and Manufacturing, to ensure the adoption and use of best practices, Quality tools, and Design Control methodologies
• Support Software Quality Assurance (SQA) strategy and operational execution plans
• Knowledge of and experience in developing and medical devices in conformance with Quality System Regulations, ISO13485, ISO14971, ISO62304 and SW96 requirements.
• Applies knowledge of IEC 62304 to product development and sustaining engineering 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, disposables, 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 contribute 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.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Develop and maintain strong relationships with internal and external stakeholders
• Excellent interpersonal skills
• A self-starter, motivated and able to positively motivate others
• Focused, target driven with a positive, can-do attitude
• Support internal and external audits
• Support additional activities, as assigned

Required Qualifications

• Bachelor’s degree in Computer or Engineering Science, Electrical or Software Engineering (or similar) is required. Master’s degree preferred.

• Minimum of 5 years of hands‑on experience in the Quality Engineering discipline.
• 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.
• Leadership and interpersonal skills to develop and manage good working relationships with internal departments (manufacturing, receiving, purchasing, product development, and regulatory), contractors, and suppliers.
• 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

• 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 across the business and quality management system.
• Leadership and interpersonal skills to develop and manage good working relationships with internal departments (manufacturing, receiving, purchasing, product development, and regulatory), contractors, and suppliers.

• Certified Quality Engineer a plus.
• Lead Auditor certification a plus.
• Lean Certification a plus.
• Experience with statistical analysis software a plus.

SF Bay Area Salary Range

$136,000—$184,000 USD

Company Culture

At Outset, we believe every person matters. Every Outsetter, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with intelligent speed. Our team expects nothing less than our best display of strengths and skills, and we find joy in working together for a common goal. At Outset, we believe that curiosity, ingenuity and conviction in the power of technology will transform the lives of dialysis patients and providers.

We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU, our future Outsetter. At Outset, we've designed a professional world that our employees are honored and impassioned to belong to, one that offers challenge, the ability to collaborate with great people, and opportunities to build skill and expertise in a fulfilling career.

An opportunity at Outset Medical won’t just be about finding a job. Our culture revolves around the principles of moving farther, faster, together, so working here feels like a masterclass in peak performance, for individuals and teams.

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EQUAL EMPLOYMENT OPPORTUNITY STATEMENT

Outset Medical is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws. This policy applies to all employment practices within our organization.