Prin Quality Engineer

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

About the role

Medtronic is seeking a highly skilled and experienced Principal Risk Management Quality Engineer to join our innovative team in the surgical operating unit within the new product development quality team. This position plays a critical role in the development of medical devices, ensuring patient safety is embedded throughout the product lifecycle. The ideal candidate will have a strong background in risk management, product development, design controls, and regulatory compliance within the medical device industry. This role requires a strong team player who is a self-starter, inquisitive, and a fast learner.

Responsibilities

• Develop and maintain comprehensive strategies for risk management activities, including:
  • Collaborating cross-functionally to ensure the utmost product quality for patient safety
  • Creating and maintaining the risk management file, including the risk management plans and reports, as well as conducting regular risk reviews
  • Leading hazard and risk analysis activities to identify potential risks and implement effective risk control measures
  • Leading Design Failure Modes and Effects Analyses (DFMEAs) in collaboration with project teams to systematically evaluate potential failure modes and their impacts
  • Analyzing and reviewing product complaints to anticipate and prevent future issues
  • Integrating product security measures to protect against potential vulnerabilities into the risk management file
  • Participating in Process FMEA/User FMEA development and integrating the Process FMEA/User FMEA into the risk management file
  • Leading design review and maintaining the risk management file throughout the product lifecycle
  • Developing and managing post-market surveillance plans to monitor product performance and safety in the field
  • Leading field issue evaluation (including root cause analysis, risk evaluation, product containment strategy) during initial launch
  • Ensuring traceability between risk management file, requirements, and design outputs utilizing a requirements management tool
• Evaluate the safety risk implications of design changes
• Lead and mentor teams in the development, implementation, and maintenance of the 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, including FDA, ISO (e.g., 14971, 13485, 62304, FDA Part 820), and other international standards, and participate in regulatory audits and inspections
• Oversee design validation and design verification activities of user needs and design inputs, including the development of test plans, protocols, test methods, and reports
• Ensure thorough and accurate documentation including test results, risk assessments, and reports

Requirements

• Minimum bachelor’s degree in engineering or a related technical field; advanced degree preferred
• In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards
• Strong analytical and problem-solving skills with the ability to conduct thorough root cause analysis
• Excellent written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams and present complex information to stakeholders
• Proven leadership and project management skills with the ability to lead teams and manage multiple projects simultaneously

Qualifications

• Preferred Certifications: Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification, AAMI design control certification
• Preferred Experience: Regulated engineering field, medical device industry
• Technical Skills: Proficient in quality management systems, risk management, regulatory compliance, and statistics
• Other: Basic knowledge of human anatomy/physiology and surgical procedures

Schedule

This role requires working a minimum of 4 days a week onsite to foster a culture of professional growth and cross-functional collaboration.

Pay

Salary ranges for U.S. locations (excluding Puerto Rico) are $120,800.00 - $181,200.00 (USD). This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location.

Benefits

The following benefits are available to regular employees who work 20+ hours per week:

• Health, dental, and vision insurance
• Health Savings Account (HSA)
• Healthcare Flexible Spending Account (FSA)
• 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 and 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)

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Some benefits may not apply to workers in Puerto Rico.