Sr. Design Quality Engineer

Senior Design Quality Engineer at Medtronic responsible for developing and evaluating medical device designs that meet product requirements while optimizing for manufacturability and reliability. The role involves design verification, statistical analysis, risk assessment, regulatory compliance, and cross-functional collaboration across the product lifecycle.

Responsibilities

• Develop and evaluate medical device designs optimized for manufacturability, reliability, and cost
• Verify product functionality through design test methodology and statistical analysis
• Conduct FMEA and process risk assessment using ISO 14971 standards
• Execute process qualification (IQ/OQ/PQ) and manage CAPA/RCA activities
• Develop and maintain regulatory documentation including PSURs, CERs, and technical files

Requirements

• Master's degree in Mechanical, Industrial, Biomedical Engineering, or related field
• 2+ years experience as quality, product, or validation engineer
• 2+ years with DMAIC methodology and statistical tools (Minitab, DOE, SPC, ANOVA)
• 2+ years with FMEA, ISO 14971, and problem-solving techniques (A3, PDCA, 5 Why's)
• 2+ years with QMS processes, FDA 21 CFR Part 820, ISO 13485, and GDP
• 2+ years with IQ/OQ/PQ, CAPA, RCA, and PPAP documentation requirements
• 2+ years with PSUR, CER, TD files per EU MDR and global regulatory requirements

Compensation: $115,000–$147,600 per year