Medical Device Embedded Software Engineer Jobs in California, MO

Staff Software Engineer, Embedded Systems – remote eligible, local San Diego, CA highly desirable. Supports R&D Software Engineering team in design and development of next‑generation diagnostic platforms.

• 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 tests to meet coverage goals.
• Fix defects found during the 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.

• Bachelor’s degree or equivalent in Software Engineering, 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.
• Ability 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.

• 5 years of experience with software development for medical devices or another regulated industry.
• Familiarity with regulated software development standards and practices (e.g., IEC 62304, ISO 13485, 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#.

• 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.

Typical remote office environment. Requires discipline, organization skills, and self‑motivation to work autonomously in a home office environment. Flexible work hours to meet project deadlines.

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

Salary range: $140,000 to $160,000, bonus eligible. Comprehensive benefits package includes medical, dental, vision, life, and disability insurance; 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 may be amended, terminated, or enhanced at the company’s discretion.

QuidelOrtho is an equal opportunity employer and is committed to ensuring all individuals, including those with disabilities, have an opportunity to apply for positions 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. For assistance with application due to a disability, contact recruiting@quidelortho.com.