This staff-level role serves as the software design assurance lead for complex, safety-critical systems spanning embedded firmware, connected devices, mobile apps, and cloud services
Job Summary
This staff-level role serves as the software design assurance lead for complex, safety-critical systems spanning embedded firmware, connected devices, mobile apps, and cloud services.
You will embed with R&D as the quality core-team representative to ensure design controls, risk management, cybersecurity, and verification/validation are planned and executed to deliver safe, effective Class III medical devices worldwide.
Abbott offers career development with an international company, excellent benefits including medical coverage and retirement savings, and tuition reimbursement programs.
Matching Summary
This staff-level role serves as the software design assurance lead for complex, safety-critical systems spanning embedded firmware, connected devices, mobile apps, and cloud services.
Salary
Base: $114,000.00 – $228,000.00; Bonus/Equity: Not specified; Benefits: Medical coverage, retirement savings plan, tuition reimbursement
Skills & Requirements
Must-have
Software Design Assurance Lead
Medical Device Software Development
Risk Management ISO 14971
IEC 62304 Compliance
FDA 21 CFR Part 820
EU MDR 2017/745
Nice-to-have
Strategic quality leadership
Cross-functional leadership
Mentoring mindset
Calm, fact-based execution
Key Requirements
Bachelor’s degree in scientific, technical, or engineering discipline
Minimum 8 years of Software Development and Design Quality Engineering experience
Knowledge of FDA regulations and guidance
Experience with medical device software development lifecycle