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.
• 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.

Position Overview  

We are looking for an experienced professional who helps provide an accurate measure of product quality through effective processes and software automation, while continually improving testing throughout the software development life cycle. This person applies both practical and theoretical knowledge in Computer Science, along with previous experience in healthcare or a related industry. Additionally, the individual is expected to have the ability to architect, create, and execute both manual and automated tests across different layers of embedded and cloud applications.

Essential Job Functions and Responsibilities

• Leverage programming skills and test fixture knowledge to design, develop, maintain, and extend software automation frameworks for embedded and cloud applications.
• Collaborate with the team to design, execute, and maintain both manual and automated test scripts across UI, backend, API, performance, scalability, and security layers based on project requirements.
• Establish and enforce quality standards, ensuring they align with project goals and application areas under control.
• Engage with developers, subject matter experts, cross-functional teams, and product management in test case reviews and execution.
• Integrate automated tests into the CI/CD pipeline, ensuring results are stored in a shared repository.
• Translate business requirements into testable features and create test scenarios that meet those needs.
• Identify, troubleshoot, and document reproducible defects, working to resolve issues efficiently with software development team members.
• Create and manage functional, non-functional, and integration testing environments; conduct root cause analysis and debugging for features with moderate complexity.
• Lead discussions with cross-functional team members to identify high-risk areas early in the development lifecycle and create strategies to mitigate those risks.
• Develop test plans, audit execution evidence, and generate test reports, adhering to structured and controlled processes.
• Analyze and verify data conversions across multiple formats to ensure accuracy and compliance with EMR systems.
• Mentor junior team members and contribute to the continuous improvement of software quality methodologies and processes.
• Lead process improvements, manage Jira verification, and facilitate CCB meetings with cross-functional teams to drive consensus and project alignment.
• Troubleshoot complex issues in existing or new software by analyzing both product behavior and code.

Required Qualifications

• Bachelor's Degree in Electrical Engineering, Computer Engineering, or a related technical field, or equivalent combination of education and experience.
• Extensive experience with software quality engineering methodologies and processes.
• 4+ years of programming experience, leveraging AI libraries and tools to enhance and extend test automation frameworks.
• 2+ years of full-stack Software Test Engineering experience.
• 4+ years of experience utilizing AI tools and libraries to enhance test automation frameworks and build test fixtures for hardware interaction.
• 4+ years of hands-on experience in test automation using Python, Robot Framework with Appium, and Selenium.
• Strong understanding of testing methodologies and strategies, including black-box, grey-box, and white-box testing, as well as feature, functional, continuous integration, continuous deployment, continuous testing, and regression testing.

Desired Qualifications

• Experience in performance and load testing for embedded and cloud applications.
• Experience implementing CI/CD pipelines for automated tests across different application layers.
• Strong background in developing and integrating test fixtures with automated tests using Python, Robotframework, or AI tools and libraries.
• Self-motivated, independent, and eager to learn new technologies.
• Detail-oriented, with strong time management skills and the ability to meet deadlines.
• Excellent interpersonal and teamwork skills, with the ability to work independently.
• Exceptional analytical skills and problem-solving abilities.
• Collaborate effectively with team members, both in person and virtually, with this role requiring regular work from the office.
• Fexible, able to work under tight deadlines in office environment, and support off-hours demands when needed.

**Relocation support may be available for qualified candidates who are open to moving to the role’s location (Tijuana, BC).**

Position Overview  

The Senior Software Developer in Test Engineer is an experienced professional who participates in providing accurate measure of product quality, processes, software automation, and continually help improve testing throughout the software development life cycle. This person applies their practical and theoretical knowledge from Computer Science and previous experience in healthcare or a related industry.   Additionally, the person is expected to have the ability to architect, create, and run both manual and automated tests for different layers of embedded and cloud application.

Essential Job Functions and Responsibilities

• Leverage programming skills and test fixture knowledge to design, develop, maintain, and extend software automation frameworks for embedded and cloud applications.
• Collaborate with the team to design, execute, and maintain both manual and automated test scripts across UI, backend, API, performance, scalability, and security layers based on project requirements.
• Establish and enforce quality standards, ensuring they align with project goals and application areas under control.
• Engage with developers, subject matter experts, cross-functional teams, and product management in test case reviews and execution.
• Integrate automated tests into the CI/CD pipeline, ensuring results are stored in a shared repository.
• Translate business requirements into testable features and create test scenarios that meet those needs.
• Identify, troubleshoot, and document reproducible defects, working to resolve issues efficiently with software development team members.
• Create and manage functional, non-functional, and integration testing environments; conduct root cause analysis and debugging for features with moderate complexity.
• Lead discussions with cross-functional team members to identify high-risk areas early in the development lifecycle and create strategies to mitigate those risks.
• Develop test plans, audit execution evidence, and generate test reports, adhering to structured and controlled processes.
• Analyze and verify data conversions across multiple formats to ensure accuracy and compliance with EMR systems.
• Mentor junior team members and contribute to the continuous improvement of software quality methodologies and processes.
• Lead process improvements, manage Jira verification, and facilitate CCB meetings with cross-functional teams to drive consensus and project alignment.
• Troubleshoot complex issues in existing or new software by analyzing both product behavior and code.

Required Qualifications

• Bachelor's Degree in Electrical Engineering, Computer Engineering, or a related technical field, or equivalent combination of education and experience.
• Extensive experience with software quality engineering methodologies and processes.
• 4+ years of programming experience, leveraging AI libraries and tools to enhance and extend test automation frameworks.
• 2+ years of full-stack Software Test Engineering experience.
• 4+ years of experience utilizing AI tools and libraries to enhance test automation frameworks and build test fixtures for hardware interaction.
• 4+ years of hands-on experience in test automation using Python, Robot Framework with Appium, and Selenium.
• Strong understanding of testing methodologies and strategies, including black-box, grey-box, and white-box testing, as well as feature, functional, continuous integration, continuous deployment, continuous testing, and regression testing.

Desired Qualifications

• Experience in performance and load testing for embedded and cloud applications.
• Experience implementing CI/CD pipelines for automated tests across different application layers.
• Strong background in developing and integrating test fixtures with automated tests using Python, Robotframework, or AI tools and libraries.
• Self-motivated, independent, and eager to learn new technologies.
• Detail-oriented, with strong time management skills and the ability to meet deadlines.
• Excellent interpersonal and teamwork skills, with the ability to work independently.
• Exceptional analytical skills and problem-solving abilities.
• Collaborate effectively with team members, both in person and virtually, with this role requiring regular work from the office.
• Fexible, able to work under tight deadlines in office environment, and support off-hours demands when needed.