Staff Software Engineer

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 6,000 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 Position

At QuidelOrtho, we’re advancing the power of diagnostics for a healthier future for all. Join our mission as our next Staff Software Engineer, Embedded Systems, to support our R&D Software Engineering team in the design and development of next-generation diagnostic platforms. This role provides technical leadership across requirements definition, software architecture, detailed design, implementation, and integration of high-quality embedded software.
 

The position is expected to drive the successful design, documentation, and delivery of application-level embedded software across real-time environments and hardware platforms (e.g., microcontrollers and SoCs), while collaborating cross-functionally to ensure technical quality, compliance, and product readiness.

This position is remote eligible but candidates local to San Diego, CA are highly desirable.

The Responsibilities

• Lead the design of software components and subsystems in alignment with system requirements and architecture
• Lead and influence computing and software architecture decisions across projects and cross-functional teams
• Develop and review code to implement new functionality, enhance existing capabilities, and uphold software quality standards
• Provide level-of-effort estimates, technical input, and risk identification to support planning and delivery commitments
• Gather and document software requirements and specifications
• Implement unit test to meet coverage goals
• Fix defects found during implementation process or reported by the software test team
• Lead complex system integration, debugging, and root-cause analysis across hardware, firmware, and software boundaries
• Drive software process definition and continuous improvement initiatives to improve quality, efficiency, and compliance
• Support and help coordinate release readiness activities, including technical review, defect resolution, and cross-functional alignment
• Perform other work-related duties as assigned.

The Individual

Required:

• Bachelor’s degree or equivalent in Software Engineering or Computer Science or related field
• 10 years of related experience as a software engineer designing and supporting development of complex embedded systems
• Expert-level programming skills in C/C++
• Repository experience such as Git or SVN
• Experience developing in Linux-based environments
• Experience working on a development team using Agile processes
• Strong knowledge of object-oriented design principles and software design patterns
• Experience developing software for low-power systems across multiple processor architectures (e.g., x86, ARM)
• Experience debugging embedded code
• Able to take complex designs from concept to implementation with minimal supervision
• Experience estimating, planning, and sequencing software development work
• Experience eliciting, documenting, and reviewing software requirements and use cases
• Demonstrates commitment to the development, implementation, and effectiveness of the QuidelOrtho Quality Management System in accordance with ISO, FDA, and other applicable regulatory requirements
• Ability to travel 5% or less, domestically, if working remotely.

Preferred:

• 5 years of experience with software development for medical devices or another regulated industry
• Familiarity with regulated software development standards and practices (for example, IEC 62304, ISO 13485, and software design controls)
• Experience with Qt and QML
• Experience with CI/CD
• Experience with secure software development practices, dependency management, and product cybersecurity considerations
• Experience with Yocto
• Experience using AI-assisted software development tools to improve engineering productivity and code quality
• Experience using different inter-processor and application level communication technologies (I2C, SPI, CANBus, UART, RS485, USB, TCP/IP)
• Experience with VB6 and C#

The Key Working Relationships

Internal Partners:

• 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
• Business Unit – customer requirements and feature design

External Partners:

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

The Work Environment

Typical remote office environment. Must have the discipline, organization skills and self-motivation to work autonomously in a home office environment. Flexible work hours to meet project deadlines.

Physical Demands

Must be able to work at desk, standing or sitting for extended periods of time. Typically, 40% of the time in meetings; 60% of the time at the desk on computer/doing paperwork/on phone, doing analytical work. Other physical demands include bending, kneeling, talking, hearing, and vision.

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.

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 [email protected].

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