Senior Systems Engineering Leader — Medical Diagnostics

Ortho Clinical Diagnostics; San Diego (CA); On-site; USD 165,000 - 180,000; Full time

Benefits offered by this job

Medical insurance

401(k) plan

Employee Stock Purchase Plan

Paid time off

Job summary

QuidelOrtho is seeking a Senior Manager of Systems Engineering to provide technical leadership for multi-disciplinary medical device systems, onsite in San Diego, CA. The role oversees architecture, integration, and verification across hardware, software, consumables, and assay integration, with a strong focus on regulatory alignment.

The candidate should bring 10+ years in engineering, a track record in bringing devices to market in regulated environments, and the ability to lead

Qualifications

• 10+ years of engineering experience with a related degree.
• Proven track record in medical device/system development and launches.
• Experience leading a systems design effort from concept to launch.
• Familiarity with ISO13485, IEC62366, IEC60601, ISO14971.
• Ability to lead cross-functional teams without direct authority.
• Willingness to travel up to 10%.

Responsibilities

• Lead systems engineering & integration initiatives in new product development programs.
• Serve as the systems engineering subject‑matter expert within the systems team.
• Oversee 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 (ISO14971, IEC62366, IEC60601, 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.

Skills

Systems engineering leadership

Cross-functional collaboration

Regulatory compliance

Documentation and traceability

Education

Bachelor’s degree in engineering or related field

Master’s degree preferred

Job description

QuidelOrtho is seeking a Senior Manager of Systems Engineering to provide technical leadership for multi-disciplinary medical device systems, onsite in San Diego, CA. The role oversees architecture, integration, and verification across hardware, software, consumables, and assay integration, with a strong focus on regulatory alignment.

The candidate should bring 10+ years in engineering, a track record in bringing devices to market in regulated environments, and the ability to lead