Senior Development Quality Engineer

Abbott • Plano, TX

3d • Onsite

About The Position

This position works out of our Plano, TX location in the Neuromodulation division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. As a Senior Design Quality Engineer, you will play a pivotal role in advancing the safety, quality, and performance of innovative Class III medical devices throughout the product lifecycle. This position leads risk management strategy across product development, post-market surveillance, supplier changes, and regulatory activities, transforming data-driven risk assessments into critical decisions that protect patients and inform field actions, design improvements, and clinical evidence generation. Working alongside cross-functional leaders in Clinical, Medical Safety, Regulatory Affairs, and Engineering, you will help shape the future of life-changing therapies while ensuring the highest standards of quality and compliance.

Requirements

• Bachelors 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

Nice To Haves

• Masters Degree in Engineering or Technical Field.
• Previous Medical Device design and development experience.
• Working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, EN 45502-1, ISO 14708, EU MDR, etc.

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.

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior