Senior Systems Engineering Lead, Medical Diagnostics

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

Job summary

QuidelOrtho in San Diego, CA is seeking a Senior Manager, Systems Engineering to drive the design, integration and verification of complex diagnostic systems for Point-of-Care instruments. This onsite role leads multi-disciplinary teams and collaborates with R&D, Quality, Regulatory and Manufacturing to translate requirements into robust, compliant solutions.

You will mentor engineers, manage external partners, and uphold ISO 13485, IEC 60601 and related standards while delivering programs from

Qualifications

• Minimum 10+ years with engineering degree; master's preferred.
• Experience leading a systems design effort for medical devices in a regulated environment.
• Experience managing external development or contract manufacturing partners.
• Familiarity with ISO 13485, IEC 62366, IEC 60601, ISO 14971.
• Strong communication and cross-functional teamwork; ability to travel up to 10%.

Responsibilities

• Lead architecture, integration, and verification of complex diagnostic systems.
• Manage interfaces with external hardware/firmware partners and internal software teams.
• Document system requirements and test plans; ensure regulatory alignment.
• Provide technical leadership to cross-functional project teams.
• Mentor junior engineers and promote continuous improvement.

Skills

Systems leadership

Medical devices

External partners

Hardware & software

ISO standards

Verification & validation

Leadership without authority

Communication

Travel up to 10%

Visa sponsorship unavailable

Education

Bachelor's degree in engineering

Master's degree preferred

Job description

QuidelOrtho in San Diego, CA is seeking a Senior Manager, Systems Engineering to drive the design, integration and verification of complex diagnostic systems for Point-of-Care instruments. This onsite role leads multi-disciplinary teams and collaborates with R&D, Quality, Regulatory and Manufacturing to translate requirements into robust, compliant solutions.

You will mentor engineers, manage external partners, and uphold ISO 13485, IEC 60601 and related standards while delivering programs from