Sr Design Quality Engineer
$98,400–$147,600 year
On-site · Lafayette, Colorado, United States
Job Summary
Senior Design Quality Engineer at Medtronic supporting Released Product Engineering within the Acute Care & Monitoring unit. Leads with quality engineering expertise to ensure design changes, sustaining engineering, and product improvements meet internal QMS standards and global regulatory requirements (ISO 13485, EU MDR, FDA QSR 21 CFR 820). Applies Design Controls, Risk Management (ISO 14971), and Change Control to drive product quality, reliability, and regulatory compliance across multiple technical domains. Partners with R&D, Regulatory Affairs, Manufacturing, and Program Management to ensure timely, compliant product changes; provides mentorship on quality engineering, risk management, and design control practices. Responsibilities include critically reviewing designs for patient safety and regulatory impact, developing verification/validation strategies, supporting CAPA and root cause analyses, and driving continuous improvement using DFSS/DFMEA and other quality methodologies.
Required Qualifications
- Bachelor’s Degree in a related field
- 4+ years of Quality experience in the medical device industry or a regulated industry with similar quality and regulatory requirements
- Working knowledge of Quality Management Systems compliant with ISO 13485, FDA Quality System Regulation (21 CFR 820), and EU MDR
- Experience applying risk management processes in accordance with ISO 14971
- Familiarity with IEC 60601 and other applicable medical electrical equipment or product-specific standards
- Experience supporting design controls, verification and validation planning, and test execution for medical device products
- Experience with CAPA, root cause investigation, and failure analysis methodologies
- Technical experience with electronic hardware systems, including PCB design, schematics, circuit analysis, and PCB assembly documentation
- Demonstrated experience leading or owning complex technical problems or cross functional projects
- Strong written and verbal communication skills with the ability to work effectively across cross functional teams
- ASQ certifications (CQE, CRE, CQA, etc.) optional but favorable
- Experience with statistical methods including hypothesis testing, ANOVA, GR&R, sampling plans, and parametric/non parametric analysis
- Using statistical software (Minitab or equivalent) optional but favorable
- Familiarity with reliability and environmental testing including HALT/HASS, shipping validation, sterilization, stability, or biocompatibility testing
- Experience with Lean, DMAIC, or DFSS methodologies
- Lean Six Sigma Green Belt or Black Belt optional
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