Senior Quality Engineer – CST – Lafayette, CO (Onsite)

Medtronic • Lafayette, CO

11d • Onsite

About The Position

The Senior Design Quality Engineer plays a critical role in ensuring product quality, safety, and regulatory compliance throughout the medical device product lifecycle, with a primary focus on product design, development, and sustaining engineering. As the quality representative on cross-functional project teams, you will provide technical leadership in design controls, risk management, verification and validation, and quality system compliance, partnering closely with Research & Development, Manufacturing, Regulatory Affairs, and Supply Chain to deliver safe, effective, and compliant medical technologies.

Requirements

• Bachelor’s degree in Engineering or Technical discipline with minimum of 4 years of relevant experience, OR Master’s degree in Engineering or Technical discipline with minimum of 2 years of relevant experience, OR PhD in Engineering or Technical discipline with minimum of 0 years of relevant experience.
• Possess unrestricted U.S. work authorization at the time of hire and for the duration of employment (for roles below Principal level).

Nice To Haves

• Experience with FDA Quality System Regulation (QSR), ISO 13485, EU MDR, and medical device design control requirements.
• Experience with Medtronic quality systems, design processes, or similar medical device quality management systems.
• Experience supporting system-level medical devices, including capital equipment and associated accessories.
• Knowledge of design transfer, supplier quality, manufacturing integration, labeling requirements, and regulatory submissions.
• Strong analytical, collaboration, communication, and influencing skills, with the ability to lead cross-functional teams and drive quality decisions without direct authority.

Responsibilities

• Serve as the Design Quality representative on new product development and sustaining engineering projects, ensuring compliance with design control and quality system requirements.
• Lead design quality activities, including design controls, risk management (DFMEA, hazard analysis, risk controls), verification and validation strategies, and design traceability.
• Review and approve design documentation, engineering changes, protocols, reports, and technical documentation to ensure product quality and regulatory compliance.
• Partner with R&D and cross-functional teams to develop risk-based verification and validation strategies and assess the quality impact of design changes, nonconformances, and CAPA activities.
• Support design transfer, supplier integration, manufacturing readiness, and product transfers to ensure successful commercialization and sustaining operations.
• Collaborate with Engineering, Manufacturing, and Supplier Quality teams to establish inspection methods, testing strategies, and quality standards that ensure product reliability and performance.
• Support internal and external regulatory inspections and audits, including FDA, ISO 13485, EU MDR, and other applicable regulatory requirements.
• Provide technical quality leadership, influence cross-functional decision-making, and drive continuous improvement initiatives that enhance product quality, compliance, and operational excellence.

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)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior