Sr Quality Engineer

Senior Risk Management Quality Engineer

Medtronic, a global leader in medical technology, services, and solutions, is seeking a highly skilled and experienced Senior 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:

• 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

Other potential responsibilities

• 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.

Qualifications:

Minimum Requirements:

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

Preferred Qualifications:

• Certifications: Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification, AAMI design control certification is preferred.
• Experience: Regulated engineering field
• Industry Experience: 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