Senior Quality Engineer - Neurovascular - Irvine, CA or Mounds View, MN (Onsite)

Medtronic; Irvine (CA); On-site; USD 96,000 - 146,000; Full time

Job summary

Join a forward-thinking company as a Senior Quality Engineer, where you'll play a crucial role in optimizing patient care through quality and safety issue resolution. In this dynamic position, you'll leverage your expertise in risk management, statistical analysis, and quality engineering to support innovative neurovascular products. Collaborate with diverse teams to drive product control and compliance, ensuring that healthcare solutions meet the highest standards. This is an exciting opportunity to make a significant impact in the medical technology field while advancing your career in a supportive environment.

Benefits

Health Insurance

Retirement Plans

Paid Time Off

Qualifications

• 4+ years of relevant experience in Quality Engineering or 2+ years with an advanced degree.
• Strong knowledge of regulatory requirements and compliance standards.

Responsibilities

• Ensure product safety and timely resolution of quality issues through evaluations.
• Manage risk throughout the product lifecycle and ensure regulatory compliance.

Skills

Statistical Analysis

Risk Management

Process Improvement

Data Analytics

Education

Bachelor’s Degree

Advanced Degree

Job description

We anticipate the application window for this opening will close on - 23 May 2025.

At Medtronic, you can begin a lifelong 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

In this role as the Senior Quality Engineer, you will be responsible for optimizing patient care by resolving post-market quality and product safety issues promptly. The position involves engineering evaluation of field-reported complaints, analyzing trends in patient impact, device failures, root cause investigations, and ongoing risk assessments driven by data analytics and signal detection for neurovascular product sustenance and improvements. You will support all Neurovascular products, applying your knowledge of Design Control, Risk Management principles, quality engineering techniques, statistics, and data analytics to monitor post-market product safety and ensure regulatory compliance. Collaboration with cross-functional teams is essential to drive appropriate product control based on risk evaluation.

Join a diverse team of innovators who bring their worldview, backgrounds, and experiences to work every day. We work hard to cultivate a workforce that reflects our patients and partners, believing it’s essential to drive healthcare forward and maintain our leadership in medical technology and solutions.

Neurovascular Operating Unit

The Neurovascular Operating Unit offers a comprehensive portfolio of proven neurovascular technologies, setting high standards of integrity and reliability in stroke care.

Location

Irvine, CA or Mounds View, MN

Responsibilities

• Issue Escalation and Evaluation: Ensuring product safety and timely resolution of quality and safety issues through evaluation and risk assessments; leading investigations of complex technical issues; evaluating the impact on products, including complaint root cause analysis, health hazard analysis, and field corrective actions; supporting complaint trending and signal analysis.
• Risk Management: Managing risk throughout the product lifecycle; evaluating test protocols; maintaining knowledge of regulatory requirements; ensuring compliance with FDA and international standards; utilizing data mining and analysis methods; understanding Neurovascular products and clinical uses.

Minimum Requirements

• Bachelor’s degree with at least 4 years of relevant experience, or an advanced degree with at least 2 years of relevant experience.

Preferred Qualifications

• Degree in Engineering, Science, or a technical discipline.
• Experience in Quality Engineering decision-making, project management, GMP, GLP, and regulatory standards.
• Certifications like ASQ (CQE, CQA) are preferred.
• Strong statistical analysis, risk management, and process improvement skills.

Physical Requirements

Details about physical demands and accommodations are provided, emphasizing mobility, interaction with computers, and communication.

Benefits & Compensation

We offer a competitive salary and benefits package, including health insurance, retirement plans, paid time off, and more. Salary range: $96,800 - $145,200 USD. Details available via the provided link.

About Medtronic

We lead in healthcare technology, committed to solving the most challenging health problems. Our mission is to alleviate pain, restore health, and extend life. We value diversity and innovation, with a global team of over 95,000 passionate people. Learn more about our mission and diversity efforts via the provided link.

Medtronic is an equal opportunity employer, providing accommodations for persons with disabilities and considering criminal history in accordance with applicable laws.