Senior Design Quality Engineer – Medical Devices

Hardware FYI; Plano (TX); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Free medical coverage in HIP PPO plan

Excellent retirement savings plan with

Job summary

Abbott in Plano, TX seeks a Senior Development Quality Engineer to advance safety, quality, and performance of Class III medical devices throughout the lifecycle. You will lead risk management across development, post-market surveillance, supplier changes, and regulatory activities, shaping data-driven decisions that protect patients and drive improvements.

You will collaborate with Clinical, Medical Safety, Regulatory Affairs, and Engineering teams to deliver robust evidence and ensure

Qualifications

• Bachelor's Degree in Engineering, Technical field OR an equivalent combination of education and work experience.
• 5+ years of previous quality engineering experience and demonstrated use of quality tools/methodologies.
• Excellent verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization.
• Strong analytical/problem solving, including knowledge of root cause investigation methodologies and statistical/data analysis

Responsibilities

• Serve on product development teams promoting and assuring quality in product development projects.
• Lead and influence the integration of risk management into product development, sustaining engineering, supplier changes, and post-market activities in accordance with ISO 14971, FDA QMSR, EU MDR, and industry best practices.
• Partner with Clinical, Medical Safety, Regulatory Affairs, R&D, and Post-Market Surveillance teams to generate and evaluate risk-based evidence supporting critical business and patient safety decisions.
• Drive development of objective, measurable, clinically relevant, and verifiable customer, user, and system requirements that address identified hazards and risk control measures.
• Collaborate with Clinical and Medical Affairs teams to determine when additional clinical evidence, post-market clinical follow-up, or formal clinical investigations may be necessary to address residual risks, safety signals, or evolving benefit-risk profiles.
• Accountable for Applicable Standards Document & checklists, Labeling Verification planning & execution, Essential Output reports, and General Safety and Performance Requirements (GSPR).
• Lead cross-functional risk reviews and facilitate executive-level discussions regarding risk acceptability, risk control effectiveness, and benefit-risk tradeoffs for complex product and quality issues.
• Ensure complete, accurate, and inspection-ready Design History File (DHF) documentation, with particular focus on traceability between hazards, risk controls, design requirements, verification activities, validation evidence, and post-market performance.
• Apply advanced quality engineering and problem-solving methodologies to investigate complex issues, identify root causes, prioritize corrective actions, and drive sustainable improvements.
• Accountable for applicable standards assessments, regulatory compliance documentation, labeling verification activities, Essential Requirements/GSPR evaluations, and evidence demonstrating safety and performance.
• Partner effectively with employees, customers, suppliers, contract manufacturers, and external stakeholders to ensure alignment on quality and risk-related objectives.
• Ensure compliance with FDA regulations, EU MDR requirements, ISO standards, company policies, and global regulatory expectations while championing a proactive risk-based quality culture.

Skills

Quality engineering

Root cause analysis

Data analysis

Communication

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Job description

Abbott in Plano, TX seeks a Senior Development Quality Engineer to advance safety, quality, and performance of Class III medical devices throughout the lifecycle. You will lead risk management across development, post-market surveillance, supplier changes, and regulatory activities, shaping data-driven decisions that protect patients and drive improvements.

You will collaborate with Clinical, Medical Safety, Regulatory Affairs, and Engineering teams to deliver robust evidence and ensure