Sr Quality Engineer

Medtronic•Lafayette, CO

1d•$98,400 - $147,600•Onsite

About The Position

Medtronic is seeking a Senior Risk Management Quality Engineer for the surgical operating unit’s new product development quality team. The role applies risk management, product development, design controls, and regulatory compliance expertise to help embed patient safety throughout the medical-device product lifecycle. The position requires a collaborative, self-starting, inquisitive, and fast-learning team member. The engineer develops and maintains risk-management strategies and records; leads hazard, risk, and failure-mode analyses; evaluates design changes and field issues; and works with cross-functional teams on quality systems, product validation and verification, and regulatory compliance. The role also supports regulatory audits and inspections and ensures accurate documentation and traceability across risk files, requirements, and design outputs. The position is based on an onsite work model requiring at least four days per week in person. The anticipated application window closes October 30, 2026. The U.S. salary range, excluding Puerto Rico and specified California locations, is $98,400 to $147,600, and the role is eligible for the Medtronic Incentive Plan. Benefits and additional compensation are described as applying to eligible regular employees, with eligibility dependent on hours worked and employee status.

Requirements

Bachelor’s degree or higher in engineering or a related technical field.
In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards.
Strong analytical and problem-solving skills, including the ability to conduct thorough root-cause analysis.
Excellent written and verbal communication skills, including the ability to collaborate with cross-functional teams and present complex information to stakeholders.
Proven leadership and project-management skills, including the ability to lead teams and manage multiple projects simultaneously.
For baccalaureate degrees earned outside the United States, a degree satisfying the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Roles below Principal level require unrestricted U.S. work authorization at hire and throughout employment; sponsorship is offered exclusively for Principal-level roles and above.

Nice To Haves

Advanced degree.
Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification, or AAMI design control certification.
Experience in a regulated engineering field.
Medical-device industry experience.
Proficiency in quality-management systems, risk management, regulatory compliance, and statistics.
Basic knowledge of human anatomy and physiology and surgical procedures.

Responsibilities

Develop and maintain comprehensive strategies for risk-management activities.
Collaborate cross-functionally to support product quality and patient safety.
Create and maintain the risk-management file, including plans and reports, and conduct regular risk reviews.
Lead hazard and risk analyses to identify potential risks and implement risk-control measures.
Lead Design Failure Modes and Effects Analyses (DFMEAs) with project teams.
Analyze and review product complaints to anticipate and prevent future issues.
Integrate product-security measures addressing potential vulnerabilities into the risk-management file.
Participate in Process FMEA and User FMEA development and integrate those analyses into the risk-management file.
Lead design reviews and maintain the risk-management file throughout the product lifecycle.
Develop and manage post-market surveillance plans to monitor product performance and field safety.
Lead field-issue evaluation during initial launch, including root-cause analysis, risk evaluation, and product-containment strategy.
Ensure traceability between the risk-management file, requirements, and design outputs using a requirements-management tool.
Evaluate safety-risk implications of design changes.
Lead and mentor teams developing, implementing, and maintaining quality-system processes and standards.
Collaborate with cross-functional teams to define and implement engineering and statistical processes that ensure product quality and compliance throughout the product lifecycle.
Ensure compliance with relevant regulatory requirements and standards, and participate in regulatory audits and inspections.
Oversee design validation and verification of user needs and design inputs, including development of test plans, protocols, test methods, and reports.
Ensure thorough and accurate documentation, including test results, risk assessments, and reports.

Benefits

Competitive salary and flexible benefits package.
Health insurance, dental insurance, and vision insurance for eligible regular employees working 20 or more hours per week.
Health Savings Account and Healthcare Flexible Spending Account for eligible regular employees working 20 or more hours per week.
Life insurance and long-term disability leave for eligible regular employees working 20 or more hours per week.
Dependent daycare spending account for eligible regular employees working 20 or more hours per week.
Tuition assistance or reimbursement for eligible regular employees working 20 or more hours per week.
Simple Steps global well-being program for eligible regular employees working 20 or more hours per week.
Incentive plans for regular employees.
401(k) plan with employer contribution and match for regular employees.
Short-term disability for regular employees.
Paid time off and paid holidays for regular employees.
Employee Stock Purchase Plan for regular employees.
Employee Assistance Program for regular employees.
Non-qualified Retirement Plan Supplement, subject to IRS earning minimums, for regular employees.
Capital Accumulation Plan for Vice Presidents and above or subject to IRS earning minimums.
Short-term incentive eligibility through the Medtronic Incentive Plan.