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, ISO *****, ISO *****, ISO ***** and SW96 requirements
Applies knowledge of IEC ***** 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 *****:**** (quality system) requirements, ISO ***** (risk management) requirements, ANSI/AAMI SW96, knowledge of good manufacturing practices (GMP) and applicable quality system standards
Strong written and verbal communication skills
Must be able to communicate fluently in both written and spoken English
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
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.
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📌 Senior Software Quality Engineer (Tijuana)
🏢 Outsetmedical
📍 Tijuana