Sr Design Quality Engineer

Medtronic•Lafayette, CO

1d•$98,400 - $147,600•Onsite

About The Position

The Senior Design Quality Engineer, supporting Released Product Engineering (RPE) within the Acute Care & Monitoring (ACM) Operating Unit, drives product quality, reliability, and regulatory compliance through technical expertise and cross‑functional leadership. This role partners with R&D, regulatory, manufacturing, and program teams to ensure design changes and sustaining engineering activities meet internal quality standards and global regulatory requirements. The Senior Design Quality Engineer plays a critical role in applying Design Controls, Risk Management, and Change Control processes to evaluate, implement, and release product improvements across the ACM product portfolio. If you are passionate about solving complex technical problems, improving product quality, and collaborating across disciplines to deliver safe and reliable medical devices, this role offers an opportunity to make meaningful impact.

Requirements

Bachelor’s Degree.
4+ years of Quality experience with a Bachelors Degree OR 2+ years of Quality experience with a Masters Degree
Experience in the medical device industry or in 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

Nice To Haves

ASQ certifications (CQE, CRE, CQA, etc.)
Experience with statistical methods including hypothesis testing, ANOVA, GR&R, sampling plans, and parametric/non parametric analysis
Experience using statistical software (Minitab or equivalent)
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

Responsibilities

Critically review new and modified product designs to evaluate impact on product requirements, patient safety, reliability, and regulatory compliance.
Ensure design changes are executed in accordance with Medtronic’s Quality Management System (QMS) and applicable global regulations including ISO 13485, EU MDR, and FDA Quality System Regulation (21 CFR Part 820).
Lead cross-functional teams in the development and maintenance of risk management documentation including Risk Management Plans, hazard analyses, DFMEAs, and Risk Management Reports in accordance with ISO 14971.
Support development and review of verification and validation strategies, including test plans, protocols, and reports, ensuring alignment with product requirements and applicable standards.
Provide quality engineering support for sustaining engineering initiatives across multiple technical domains including electrical, software, mechanical, optical, algorithms, and human factors.
Collaborate with cross-functional partners including R&D, Operations, Regulatory Affairs, Marketing, and Program Management to ensure timely and compliant execution of product changes.
Apply Design for Reliability, Manufacturability, and Design for Six Sigma (DFSS) methodologies to improve product performance and reduce risk.
Drive continuous improvement initiatives that enhance product quality, reliability, and manufacturing robustness.
Provide technical guidance and mentorship to engineers on quality engineering principles, risk management practices, and design control requirements.