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

Senior Manager, Systems Engineering

At Quidel Ortho, we’re advancing the power of diagnostics for a healthier future. This Senior Manager of Systems Engineering provides technical leadership and accountability for the development of complex, multi‑disciplinary systems—spanning hardware, software, consumables, and assay integration in complex diagnostic systems. The position is onsite full‑time in San Diego, CA.

• Lead systems engineering & integration initiatives in new product development programs.
• Serve as the systems engineering subject‑matter expert within the 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.
• Ensure accurate documentation of system requirements, interface specifications, and integration test plans, data, and decisions.
• Provide solutions to complex system‑level technical problems and collaborate cross‑functionally to define, decompose, verify, and validate system requirements.
• Conduct system‑level risk analysis and implement mitigation strategies.
• Ensure compliance with relevant ISO standards (ISO
  14971, IEC
  62366, IEC
  60601, etc.).
• Interface with manufacturing partners for effective system design transfer.
• Serve as the technical liaison between partners and internal teams.
• Lead cross‑functional project teams including R&D, Quality, Manufacturing, Regulatory, and 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 systems engineering principles and best practices.
• Foster a culture of continuous improvement and technical excellence.
• Keep abreast of and share knowledge of updates to technical standards.
• Perform other work‑related duties as assigned.

• Minimum of 10+years of experience with a bachelor’s degree in engineering or a related field; master’s degree preferred or equivalent education and experience.
• Proven track record of successfully bringing medical devices or point‑of‑care IVD instruments from concept to commercial launch in a regulated environment.
• Demonstrated experience leading a systems design effort from concept to commercial launch.
• 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 software engineering, with working knowledge of 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 lead without direct authority and influence cross‑functional teams.
• Strong communication, analytical, and teamwork skills.
• Ability to travel up to 10%.
• Position is not currently eligible for visa sponsorship.

• Internal Partners
  • Engineering Team
  • Program Managers
  • Assay Development Scientists
  • Manufacturing Team
  • Design Quality
  • Regulatory Affairs
• External Partners
  • Contract design and manufacturers
  • Electrical Safety Test contacts
  • Vendors

• 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…