Senior Design Quality Engineer - CST - Fort Worth, TX (Onsite)
Medtronic•Fort Worth, TX
•Onsite
About The Position
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
- Applicants must be authorized to work in the country of employment without sponsorship.
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.
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
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
