Senior Design Quality Engineer - CST - Fort Worth, TX (Onsite)
About The Position
As one of three comprehensive portfolios at Medtronic, Neuroscience is dedicated to improving the lives of people living with neurological disorders, spine conditions, and chronic pain. Guided by our Mission—to alleviate pain, restore health, and extend life—we develop technologies and therapies that help people regain function, reduce pain, and return to the activities that matter most. Our Cranial & Spinal Technologies (CST) Operating Unit develops and delivers an integrated ecosystem of spinal implants, navigation and robotic guidance systems, advanced imaging, and data-driven planning tools for complex spine and cranial procedures. Platforms such as AiBLE™ connect these technologies to enhance surgical precision, streamline workflows, and support improved patient outcomes across the globe. In this exciting role as a Senior Design Quality Engineer, you will partner with cross-functional teams to ensure quality is integrated throughout the product development lifecycle, from concept through commercialization and sustaining engineering. You will work closely with R&D, Regulatory, Clinical, Operations, and Manufacturing to support Design Quality execution, risk management, design verification and validation, and compliant product development. This role plays a critical part in ensuring products meet quality, regulatory, and customer requirements while supporting continuous product improvements and successful design transfers to manufacturing.
Requirements
- Bachelor’s degree in Engineering or Technical field with minimum of 4 years of relevant experience, OR
- Master’s degree in Engineering or Technical field with minimum of 2 years of relevant experience, OR
- PhD with 0 years of relevant experience
Nice To Haves
- Experience in medical device or other highly regulated industry.
- Experience supporting combination products, including drug delivery systems, biologics, or other combination device technologies.
- Experience with product lifecycle management, sustaining engineering, and design changes
- Knowledge of Design Controls, Design Verification & Validation (V&V), and Risk Management (ISO 14971).
- Familiarity with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and global medical device regulations.
- Exposure to Design History Files (DHF), traceability, and technical documentation.
- Experience with statistical analysis, root cause investigations, and quality improvement methodologies.
- Experience supporting design transfer and manufacturing readiness activities.
- Strong cross-functional collaboration skills with R&D, Regulatory, Clinical, Operations, and Manufacturing teams.
Responsibilities
- Partner with cross-functional teams to integrate Design Quality requirements into product development and lifecycle management activities.
- Support Design Quality execution from concept through commercialization, design changes, and sustaining engineering.
- Contribute to risk management activities, including risk identification, assessment, mitigation, and traceability throughout product development.
- Support design verification and validation activities to ensure products meet quality, safety, and regulatory requirements.
- Develop and maintain objective evidence, design documentation, and Design History File (DHF) records to support compliant product development.
- Apply quality system and regulatory requirements to design changes, product modifications, and lifecycle management activities.
- Support design transfer activities by partnering with Operations and Manufacturing to ensure quality requirements are effectively implemented.
- Develop, apply, and maintain quality standards, inspection methods, testing protocols, and quality documentation.
- Collaborate with Engineering and Manufacturing to establish quality processes and ensure product and process compliance.
- Perform quality analysis, inspection planning, statistical analysis, and support corrective and preventive actions to improve product quality and reliability.
- Support quality activities involving suppliers, externally developed components, and manufacturing processes to ensure compliance with applicable standards.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
