Sr. Manager, Systems Engineering, Point-Of-Care

The Opportunity

Quidel Ortho 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.

At Quidel Ortho we're advancing the power of diagnostics for a healthier future for all. Join our mission as our next Senior Manager, Systems Engineering, supporting our Point‑of‑Care instruments.

This Senior Manager of Systems Engineer provides technical leadership and accountability for the development of complex, multi‑disciplinary systems‑spanning hardware, software, consumable and assay integration in complex diagnostic systems. The role will lead system design efforts to collaborate with engineers, scientists, and cross‑functional partners to investigate, design, and resolve system‑level technical challenges.

This position will be onsite full‑time in San Diego, CA (Summers Ridge
- Sorrento Valley).

• Systems lead in new product development programs
• Systems Engineering subject matter expert within systems team
• Oversee the architecture, integration, and verification of complex diagnostic systems, ensuring alignment with product requirements and regulatory standards.
• Manage integration activities between external hardware/firmware development partners and internal software engineering teams
• Ensures accurate documentation of system requirements, interface specifications, and integration test plans data, and decisions
• Provides solutions to complex system‑level technical problems
• Collaborates cross‑functionally to define, decompose, verify, and validate system requirements
• Conduct system level risk analysis and ensure mitigation strategies are implemented
• Ensure compliance with relevant ISO standards (ISO 14971, IEC 62366, IEC 60601, etc.)
• Interfaces with manufacturing partners for effective system design transfer

• Serve as the technical liaison between partners and internal teams
• Technical Lead for cross‑functional project teams including but not limited to R&D, Quality, Manufacturing, Regulatory, Clinical Affairs.
• Facilitate effective communication and problem‑solving across distributed teams
• Drive technical decision‑making and resolve integration challenges
• Present technical updates to senior leadership and stakeholders

• Mentor and provide technical guidance to junior engineers on system engineering principles and best practices
• Foster a culture of continuous improvement and technical excellence
• Keep abreast and share knowledge of updates to technical standards
• Perform other work‑related duties as assigned

• Minimum of 10+ years' experience with bachelor's degree in engineering or related field, master's degree preferred; and/or equivalent combination of education and experience.
• Proven track record of successfully bringing medical devices or Point of Care IVD instruments Demonstrated experience leading a systems design effort from concept to commercial launch in a regulated environment.
• Experience in medical devices/diagnostics and regulated environments
• Experience managing external development partners and/or working with contract manufacturing partners
• Experience and training in a specific discipline such as Mechanical, Electrical, Fluidics or SW engineering working knowledge in both hardware and software systems
• Strong Familiarity with ISO 13485, IEC 62366, IEC 60601, ISO 14971 standards
• Understanding of verification and validation strategies for complex systems
• Proven ability to…