Ortho-Clinical Diagnostics

Staff Software Test Engineer, Embedded Systems

Ortho-Clinical Diagnostics$140K — $160K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a STEM field or equivalent experience
  • 7+ years of software testing experience
  • Proficiency in scripting languages such as Python
  • Experience testing embedded software in Linux environments
  • Skilled in designing and maintaining automated testing systems
  • Familiar with Agile development processes
  • Excellent communication and organizational skills

Responsibilities

  • Own technical testing strategy for software systems and execute throughout the development lifecycle
  • Create and verify detailed test plans and cases based on requirements
  • Design automation-ready test cases and collaborate on scripting
  • Lead testing efforts for medical software, ensuring quality and compliance
  • Work with Project Management to manage design control and testing documentation
  • Provide estimates and risk assessments to support project planning
  • Perform other duties as necessary

Benefits

  • Comprehensive medical, dental, vision, life, and disability insurance
  • 401(k) plan with employer contributions
  • Employee assistance program support
  • Employee Stock Purchase Plan
  • Paid time off plus sick time and paid holidays
Full Job Description
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 automation. In 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:
  • Bachelor's 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 they're 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 $140,000 to $160,000 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.

About Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics is a global leader in in vitro diagnostics. The company specializes in blood testing and screening products and services. Ortho-Clinical Diagnostics has over 4,500 employees and operates in more than 130 countries. The company's mission is to improve and save lives through diagnostics. Ortho-Clinical Diagnostics is committed to providing innovative solutions that help healthcare professionals make accurate and timely diagnoses.
Learn more about Ortho-Clinical Diagnostics
Size
5,000 employees
Market Cap
$4.1 billion
Industry
Founded
1979
5 Year Trend
+3.8%
NASDAQ

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