Staff Software Test Engineer, Embedded Systems

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing clinical chemistry and transfusion medicine. We are more than 6000 strong and do business in over 130 countries providing answers with fast accurate and consistent testing where and when they are needed most home to hospital lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

The Role

QuidelOrtho is seeking a Staff Software Test Engineer Embedded Systems to support our R&D Software Engineering team in testing and verifying new capabilities of next-generation diagnostic platforms and developing automated test suites. This includes leading the testing of end-to-end workflows that span instrument functionality device configuration cloud connectivity and system interoperability. You will have the opportunity to own and design automation-ready tests execute automated test suites and support the ongoing maintenance and troubleshooting of instrument test parallel the team is modernizing our instrument software to support domestic and international growth through modular architecture enhanced instrument-to-cloud connectivity improved cybersecurity and scalable testing practices.

This position will be hybrid in San Diego CA (roughly 1 day-onsite).

The Responsibilities

• Own the technical testing approach for instrument software systems shaping test strategy risk-based coverage and execution across the development lifecycle while partnering with engineering quality and regulatory teams to ensure robust compliant verification.
• Author execute and verify test plans and test cases to cover documented requirements for instrument software.
• Design automation-ready test cases collaborate with engineers implementing test scripts execute automated tests and help analyze and troubleshoot automated test frameworks.
• Lead and work hands-on with internal and third-party development teams with direct responsibility for testing and ensuring quality for medical instrument software with cloud and connectivity integrations.
• Collaborate with Project Management as needed to ensure design control and testing documentation are properly managed in an FDA-regulated environment.
• Provide level-of-effort estimates technical input and risk identification to support planning and delivery commitments
• Perform other work-related duties as assigned

Required Skills:

• Bachelors degree in a STEM field or equivalent experience
• 7 years of software testing experience
• Experience with scripting languages such as Python
• Experience testing embedded software
• Experience testing in Linux-based environments
• Experience designing implementing and maintaining automated test systems with tools such as Squish Robot Framework etc.
• Planning writing and executing test plans and test cases
• Effective communicator with excellent organizational skills
• Experience working on a development team using Agile processes
• Experience estimating planning and sequencing software testing work
• Demonstrates commitment to the development implementation and effectiveness of the QuidelOrtho Quality Management System in accordance with ISO FDA and other applicable regulatory requirements

Preferred Skills:

• Familiarity with regulated software development standards and practices (for example IEC 62304 ISO 13485 and software design controls)
• Experience testing Qt and QML applications with Squish
• Experience with CI/CD tools for example GitHub Actions
• Experience using AI-assisted software testing tools to improve engineering productivity and testing quality

Internal Customers:

• Systems and Hardware Engineering system requirements and architectural alignment
• Verification & Validation verification strategy execution and evidence
• Design Quality & Regulatory Affairs compliance with FDA ISO 13485 IEC 62304 and internal procedures
• Clinical Operations Manufacturing downstream readiness and operational impact

External Customers:

• Third-party software development partners
• Tooling cybersecurity and cloud service vendors
• External auditors and regulatory bodies as applicable

How We Work

At QuidelOrtho our culture is shaped by four core behaviors that guide how we collaborate make decisions and support each other and those we serve. The ideal candidate will exhibit these behaviors as we believe theyre essential to how we thrive as a team and achieve meaningful impact:

• Thrive Together Collaborate intentionally grow as a team
• Make It Happen Focus on priorities embrace continuous improvement
• Commit to Service Cultivate a service mindset
• Embrace Inclusion Be open and authentic welcome diverse perspectives

The Work Environment

No strenuous physical activity though occasional light lifting of files and related materials is required. 30% of time in meetings working with team or talking on the phone 70% of the time at the desk on computer doing analytical work. Minimal travel required. Travel includes airplane automobile travel and overnight hotel.

Physical Demands

No strenuous physical activity required. Occasional light lifting of materials may be needed. Substantial time will be spent in virtual or in-person meetings engaging with customers and working on scientific content and documentation.

Salary Transparency

The salary range for this position takes into account a wide range of factors including education experience knowledge skills geography and abilities of the candidate in addition to internal equity and alignment with market data. At QuidelOrtho it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $140000 to $160000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical dental vision life and disability insurance along with a 401(k) plan employee assistance program Employee Stock Purchase Plan paid time off (including sick time) and paid Holidays. All benefits are non-contractual and QuidelOrtho may amend terminate or enhance the benefits provided as it deems appropriate.

Equal Opportunity

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals including individuals with disabilities have an opportunity to apply for those positions that they are interested in and qualify for without regard to race religion color national origin citizenship sex sexual orientation gender identity age veteran status disability genetic information or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability please contact us at .

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