Design Quality Engineer II

Medtronic•Lafayette, CO

8d•$79,200 - $118,800•Onsite

About The Position

The Design Quality Engineer II, supporting Released Product Engineering (RPE) within the Acute Care & Monitoring (ACM) Operating Unit, contributes to product quality, reliability, and regulatory compliance through quality engineering support for sustaining engineering and product change activities. This role partners with R&D, Regulatory Affairs, Manufacturing, Operations, and Program teams to help ensure design changes and released product engineering activities are executed in accordance with Medtronic’s Quality Management System (QMS), applicable standards, and global regulatory requirements. The Design Quality Engineer II applies Design Controls, Risk Management, and Change Control processes to support evaluation, implementation, and release of product improvements across the ACM product portfolio. If you are passionate about solving technical problems, improving product quality, and collaborating across functions to support safe and reliable medical devices, this role offers an opportunity to make meaningful impact while continuing to grow your design quality engineering expertise.

Requirements

Bachelor’s degree in Engineering, Science, or a related technical discipline and a minimum of 2 years of relevant Engineering, Quality, or regulated industry experience; or an advanced degree with relevant academic, project, internship, or industry experience.
Experience in the medical device industry or another regulated industry with similar quality and regulatory requirements.
Working knowledge of Quality Management Systems and regulated product development or sustaining engineering processes.
Familiarity with ISO 13485, FDA Quality System Regulation / QMSR expectations, EU MDR, or other applicable medical device regulatory frameworks.
Familiarity with risk management principles, including ISO 14971, hazard analysis, FMEA, or risk-benefit documentation.
Experience supporting design controls, verification and validation activities, design changes, or product lifecycle documentation.
Ability to review technical documentation and assess potential quality, safety, reliability, and compliance impacts.
Experience supporting CAPA, root cause investigation, nonconformance evaluation, issue assessment, or failure analysis.
Strong written and verbal communication skills with the ability to work effectively across cross-functional teams.
Demonstrated ability to manage assigned tasks, document decisions clearly, and escalate issues appropriately.

Nice To Haves

Medical device design quality, sustaining engineering, released product engineering, or product development experience.
Experience with electronic hardware systems, PCB assemblies, schematics, circuit analysis, or related technical documentation.
Familiarity with IEC 60601 or other applicable medical electrical equipment/product-specific standards.
Experience with statistical methods such as hypothesis testing, ANOVA, GR&R, sampling plans, or parametric/non-parametric analysis.
Experience using statistical software such as Minitab or equivalent.
Familiarity with reliability or environmental testing, including HALT/HASS, shipping validation, stability, sterilization, or biocompatibility testing.
Experience with Lean, DMAIC, DFSS, or structured problem-solving methodologies.
ASQ certification such as CQE, CRE, CQA, or equivalent quality certification.
Lean Six Sigma Green Belt or Black Belt.

Responsibilities

Review new and modified product designs to help assess impact to product requirements, patient safety, reliability, standards compliance, and regulatory requirements.
Support design change activities in accordance with Medtronic’s QMS and applicable global regulations and standards, including ISO 13485, EU MDR, and FDA Quality System Regulation / QMSR expectations.
Support the development and maintenance of risk management documentation, including Risk Management Plans, hazard analyses, DFMEAs, risk assessments, and Risk Management Reports in accordance with ISO 14971.
Review and provide input to verification and validation strategies, test plans, protocols, reports, and supporting documentation to help ensure alignment with product requirements and applicable standards.
Provide quality engineering support for sustaining engineering initiatives across technical disciplines such as electrical, software, mechanical, optical, algorithms, human factors, and data analysis.
Collaborate with cross-functional partners including R&D, Operations, Regulatory Affairs, Marketing, Manufacturing, and Program Management to support timely and compliant execution of product changes.
Support investigations, issue evaluation, CAPA activities, root cause analysis, and failure analysis as needed for released product quality concerns.
Apply quality engineering tools and problem-solving methods to help identify risks, evaluate data, and support product and process improvements.
Contribute to continuous improvement initiatives that enhance product quality, reliability, manufacturability, and compliance.
Communicate technical and quality information clearly through documentation, review comments, meetings, and cross-functional collaboration.