Principal Quality Engineer - Risk Management
About The Position
At Medtronic, you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Medtronic, a global leader in medical technology, services, and solutions, is seeking a highly skilled and experienced Principal Risk Management Quality Engineer to join our innovative team. This role will be in the surgical operating unit within the new product development quality team. The ideal candidate will have a strong background in risk management, product development, design controls and regulatory compliance within the medical device industry. This position requires a strong team player who is a self-starter, inquisitive, and a fast learner. This position plays a critical role in the development of medical devices, ensuring patient safety is embedded throughout the product lifecycle.
Requirements
- Minimum bachelor’s degree 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 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.
- Regulated engineering field
- Medical device industry.
- Proficient in quality management systems, risk management, regulatory compliance, and statistics.
- Basic knowledge of human anatomy/physiology and surgical procedures
- U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Nice To Haves
- Advanced degree is preferred
- Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification, AAMI design control certification is preferred.
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.
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)
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What This Job Offers
Job Type
Full-time
Career Level
Principal
