Abbott · 16 hours ago
Software Development Quality Engineer
Plano, TX
Full-time
Onsite
Entry, Mid Level
$68K/yr - $136K/yr
2+ years expAbbott is a global healthcare leader that helps people live more fully at all stages of life. As a Software Development Quality Engineer, you will serve as a quality champion within product development, ensuring software and system designs meet the highest standards of patient safety and regulatory compliance.
BiotechnologyMedical DeviceHealthcareWellnessManufacturingPharmaceuticalLife ScienceEmergency MedicineGeneticsHealth CareHealth DiagnosticsMedicalNutrition
Responsibilities
Serve as the primary quality representative on cross-functional development teams for software-enabled implantable medical devices
Ensure all product development activities comply with design control requirements and align with patient safety and clinical performance objectives
Review and approve requirements, design, development and verification/validation deliverables in compliance with FDA QSR requirements and applicable ISO/IEC standards
Ensure compliance with IEC 62304 software lifecycle processes, including software safety classification, Software development planning, requirements, architecture, detailed design, integration testing, system and software level verification, maintenance, and issue resolution
Provide quality engineering oversight for AI/ML‑enabled software features, ensuring model design, training, and validation aligned with regulatory and safety expectations for medical devices
Evaluate risk controls and ensure traceability between hazards, requirements, risk mitigations, and verification evidence
Lead Risk Management activities (ISO 14971) including risk management plan/report, hazard analysis and Software FMECA
Ensure continuous risk acceptability through analysis of post‑market data and clinical feedback
Support design control deliverables for new product development, Software/firmware changes, Cybersecurity‑related updates
Apply risk‑based, structured problem‑solving to identify, prioritize, and resolve quality issues; participate in root‑cause investigations and drive effective corrective/preventive actions
Ensure integrity and completeness of the Design History File (DHF) and alignment with FDA Quality System Regulation (QSR) and ISO 13485 requirements
Participate in internal and external audits, and support regulatory submissions
Champion continuous improvement in software quality processes, contribute to updates of risk management processes, design control workflows, and software validation best practices
Accountable for Applicable Standards Document & checklists, Labeling Verification planning & execution, Essential Output reports, and General Safety and Performance Requirements (GSPR)
Qualification
Required
Bachelor's degree in Computer Science/Engineering, Biomedical Engineering, Electrical Engineering, or related technical discipline
Minimum 2 years of software quality or design quality experience in a regulated industry (medical devices preferred)
Experience with software development life cycle processes, verification/validation practices, and risk‑based quality engineering
Understanding of medical device regulatory frameworks, including IEC 62304, ISO 14971, ISO 13485, and/or FDA 21 CFR Part 820 design control requirements
Strong analytical/problem solving skills with proven ability to assess technical information, challenge design decisions objectively, and ensure compliance
Consistently demonstrates initiative, ownership and accountability
Excellent communication, critical thinking, and cross‑functional collaboration skills
Advanced computer skills, including statistical/data analysis and report writing skills
Preferred
Master's degree in Engineering or related field
3+ years of software development quality experience in a regulated industry
Experience with implantable Class III medical devices or safety‑critical embedded systems
Working knowledge of cybersecurity requirements, software configuration management, and requirements management tools (e.g., Polarion, Doors, Jira)
Knowledge of AI/ML development, including understanding of model life cycle, data preprocessing, training, validation, and performance evaluation
Ability to assess ML model risks and review technical documentation for datasets, algorithms, and model performance testing
Understanding of tools used in ML workflow management (e.g., MLFlow, TensorFlow, MLOps pipelines)
Experience with data‑driven problem solving, statistical analysis, or reliability engineering tools
Benefits
Free medical coverage in our Health Investment Plan (HIP) PPO medical plan
An excellent retirement savings plan with a high employer contribution
Tuition reimbursement
The Freedom 2 Save student debt program
FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
Company
Abbott
Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.
10001+ employees
H1B Sponsorship
Abbott has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$6.79M2011-03-15Post Ipo Debt· $0.1M
2009-03-16Post Ipo Debt· $6.69M
1980-12-12IPO
Leadership Team
Robert Ford
President & Chief Executive Officer
Mike Peterson
Senior Vice President
Recent News
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