Senior Manager, Systems Engineering — POC Diagnostics

Ortho-Clinical Diagnostics, Inc.; San Diego (CA); On-site; CAD 233,000 - 254,000; Full time

Benefits offered by this job

Benefits package

Bonus eligibility

Job summary

QuidelOrtho is seeking a Senior Manager, Systems Engineering in San Diego to lead multi-disciplinary system development for Point-of-Care instruments. You will oversee architecture, integration, and verification across hardware, software, consumables, and assay integration, coordinating with R&D, Quality, Manufacturing, and Regulatory teams.

Ideal candidates will have 10+ years in regulated medical device environments, external partner management, and strong ISO/IEC standards experience.

Qualifications

• 10+ years of engineering experience with systems development in regulated environments.
• Experience leading a systems design effort from concept to commercial launch.
• Experience with medical devices/IVD and working with external development partners.

Responsibilities

• Lead system architecture, integration, and verification of complex diagnostic systems.
• Oversee collaboration with external hardware/firmware partners and internal software teams.
• Ensure documentation of system requirements, interfaces, and test plans.

Skills

Systems Engineering

Leadership

Cross-functional collaboration

Regulatory compliance

ISO 13485 / IEC 60601

Education

Bachelor's degree in engineering or related field

Master's degree preferred

Job description

QuidelOrtho is seeking a Senior Manager, Systems Engineering in San Diego to lead multi-disciplinary system development for Point-of-Care instruments. You will oversee architecture, integration, and verification across hardware, software, consumables, and assay integration, coordinating with R&D, Quality, Manufacturing, and Regulatory teams.

Ideal candidates will have 10+ years in regulated medical device environments, external partner management, and strong ISO/IEC standards experience.