Risk Management Quality Engineer II - New Product Development (Surgical)
MedtronicAbout the role
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.
A Day in the Life
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
Medtronic, a global leader in medical technology, services, and solutions, is seeking a highly skilled and experienced 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.
Key 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,
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