Staff Systems Integration Engineer - IVD Devices

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

Job summary

Abbott, a global healthcare leader, seeks a Staff Engineer to plan and lead system integration for In Vitro Diagnostics (IVD) medical devices from concept to manufacturing. You will influence design reviews, test method development, and system performance assessments across multiple product lines.

The role requires strong technical skills, experience with DOE and V&V, and ability to work with cross-functional teams while adhering to regulatory standards.

Qualifications

• Bachelor’s degree or higher in a relevant field.
• Authorization to work in the United States without sponsorship.
• 10+ years of experience in IVD medical device development or similar.
• Strong technical writing and documentation skills.

Responsibilities

• Assess design feasibility and test product functionality.
• Lead system integration activities during product design and V&V.
• Define system architectures and maintain documentation trees.
• Collaborate with hardware, software, and reagent teams to implement designs.
• Ensure DHF documentation and regulatory compliance.
• Engage with OEMs for design evolution guidance.

Skills

System integration

Technical writing

DOE / Design of Experiment

Cross-functional collaboration

Education

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

Authorization to work in the United States without sponsorship

Job description

Abbott, a global healthcare leader, seeks a Staff Engineer to plan and lead system integration for In Vitro Diagnostics (IVD) medical devices from concept to manufacturing. You will influence design reviews, test method development, and system performance assessments across multiple product lines.

The role requires strong technical skills, experience with DOE and V&V, and ability to work with cross-functional teams while adhering to regulatory standards.