Senior Systems Integration Engineer – IVD Medical Devices

Abbott; San Diego (CA); On-site; USD 99,000 - 199,000; Full time

Job summary

Abbott in San Diego, CA is seeking a Staff Engineer, Systems Engineering to plan and lead system integration for In Vitro Diagnostics (IVD) medical devices from concept to manufacturing. You will drive DOE, V&V, requirements traceability, and DHF documentation while coordinating with hardware, software, and reagent teams.

The role demands strong analytical and technical writing skills, plus experience in risk management and cross-functional design reviews.

Qualifications

• Bachelor’s degree and authorization to work in the United States without sponsorship.
• 10+ years of hands-on experience in IVD medical device product development or system integration.
• Solid technical writing skills and the ability to work independently.

Responsibilities

• Plan and lead system integration for cross-functional product development projects.
• Develop test methods and lead V&V activities at the system level.
• Ensure traceability of requirements to design outputs and DHF documentation.
• Collaborate with hardware, software, and reagent teams to implement product designs.
• Participate in risk management (HA/FMEA) and design reviews.
• Present project results to diverse audiences and travel as needed.

Skills

System integration

DOE

V&V

Technical writing

Requirements management

Cross-functional collaboration

Analytical problem solving

Education

Bachelor’s degree in Biology/Biochemistry/Systems Engineering/Biomedical Engineering/Physics or related field

Advanced degree (Masters/PhD) in Biology/Biochemistry/Systems Engineering/Biomedical Engineering/Physics or related field

Tools

Requirements management tools

Job description

Abbott in San Diego, CA is seeking a Staff Engineer, Systems Engineering to plan and lead system integration for In Vitro Diagnostics (IVD) medical devices from concept to manufacturing. You will drive DOE, V&V, requirements traceability, and DHF documentation while coordinating with hardware, software, and reagent teams.

The role demands strong analytical and technical writing skills, plus experience in risk management and cross-functional design reviews.