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

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

Job summary

An established industry player seeks a Senior Quality Engineer to enhance patient care by resolving quality and safety issues. This role involves evaluating complaints, analyzing trends, and conducting risk assessments using data analytics. You will collaborate with cross-functional teams to ensure product safety and regulatory compliance. Join a diverse team dedicated to innovation in healthcare technology, where your contributions will directly impact patient outcomes. If you are passionate about quality engineering and improving lives through technology, this opportunity is perfect for you.

Benefits

Health Insurance

Retirement Plans

Paid Time Off

Comprehensive Benefits Package

Qualifications

• Bachelor's degree with 4+ years of experience or advanced degree with 2+ years.
• Experience in Quality Engineering and project management.

Responsibilities

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

Skills

Quality Engineering

Risk Management

Data Analytics

Statistical Analysis

Process Improvement

Education

Bachelor's Degree in Engineering or Science

Advanced Degree

Tools

Six Sigma

GMP

GLP

Job description

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

At Medtronic, you can start a lifelong career of exploration and innovation, helping to improve healthcare access and equity. You'll lead with purpose, fostering a more connected and compassionate world.

A Day in the Life

As a Senior Quality Engineer, your role will focus on enhancing patient care by resolving post-market quality and safety issues promptly. You will evaluate field-reported complaints, analyze trends, investigate root causes, and perform ongoing risk assessments using data analytics and signal detection. Your work will support all Neurovascular products, applying your knowledge of Design Control, Risk Management, quality engineering techniques, statistics, and data analytics to monitor product safety and ensure regulatory compliance. Collaboration with cross-functional teams will be essential to drive product control based on risk evaluation.

Join a diverse team of innovators who bring their unique backgrounds and experiences to work daily. We strive to reflect our patients and partners in our workforce, believing it is essential to advancing healthcare and maintaining our leadership in medical technology.

Neurovascular Operating Unit

Provides a comprehensive portfolio of neurovascular technologies, setting high standards for integrity and reliability in stroke care.

Location

Irvine, CA or Mounds View, MN

Responsibilities

• Issue Escalation and Evaluation: Ensure product safety and patient care through timely resolution of quality issues, lead investigations, evaluate impact, and support complaint trending and signal analysis.
• Risk Management: Manage risks throughout the product lifecycle, evaluate test protocols, ensure regulatory compliance, and utilize data analysis and risk management tools effectively.

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 related technical field.
• Experience in decision-making in Quality Engineering, project management, GMP, GLP, and regulatory standards.
• Certifications such as ASQ (CQE, CQA) preferred.
• Strong statistical and risk analysis skills, familiarity with process improvement methodologies like Six Sigma, DOE, Lean, and knowledge of ISO standards.

Physical Requirements

Standard physical demands for office roles, including mobility, computer interaction, and communication. Reasonable accommodations available.

Benefits & Compensation

Competitive salary ($96,800 - $145,200) and a comprehensive benefits package, including health insurance, retirement plans, paid time off, and more. Details available at the provided link.

About Medtronic

Leading global healthcare technology company committed to solving health problems and improving lives through innovation. Our diverse team of over 95,000 engineers and professionals is dedicated to making a difference.

We are an equal opportunity employer, providing accommodations for individuals with disabilities and considering applicants with criminal records in accordance with applicable laws.