Senior Quality Engineer - Neurovascular

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

Job summary

An established industry player is seeking a Senior Quality Engineer to join their Neurovascular team. This role involves collaborating with various departments to ensure product reliability and compliance with quality standards. You will develop and validate testing methods, perform statistical analyses, and manage risk assessments. The position offers a competitive salary and benefits, with opportunities for professional growth in a dynamic environment dedicated to advancing healthcare technology. If you are passionate about quality engineering and making a difference, this role is for you.

Benefits

Comprehensive Health Benefits

401(k)

Paid Time Off

Incentive Plans

Qualifications

• 4 years relevant experience in quality engineering or advanced degree with 2 years experience.
• Knowledge of FDA regulations and ISO standards.

Responsibilities

• Collaborate with teams to ensure product quality and compliance.
• Develop inspection and testing methods for neurovascular products.

Skills

Statistical Analysis

Quality Engineering

Risk Management

Inspection Method Development

Regulatory Compliance

Root Cause Analysis

Education

Bachelor's Degree

Master's or PhD in Engineering, Material Science, or Chemistry

Tools

Minitab

QAD

SAP

Job description

Senior Quality Engineer - Neurovascular

Overview

Location: Irvine, California, United States (onsite 3 days a week)

Type: Full-time, Remote options available

Application Deadline: 11 May 2025

Requisition ID: R29324

At Medtronic, you can start a career that makes a difference. Join us in advancing equitable and innovative healthcare accessible to all. Your efforts will help remove barriers and foster innovation in a connected, compassionate world.

About the Role

Join our diverse team of Design Quality Engineers supporting both sustaining and new product development projects within the Neurovascular business, which develops products for brain and stroke therapies.

Key Responsibilities

• Collaborate with R&D, Regulatory, Operations, and Process Engineering to ensure high reliability, safety, and compliance with quality systems.
• Develop and validate inspection and testing methods.
• Perform statistical analysis to support quality decisions.
• Support CAPA, NCR, Field Corrective Actions, and product investigations.
• Ensure design control requirements are met, and products comply with industry standards and regulations.
• Work with vascular devices and related products to ensure quality.
• Utilize statistical tools (DOE, SPC, ANOVA, etc.) with proficiency in Minitab.
• Manage risk assessments using PFMECA and DFMECA.
• Navigate standards such as FDA 21CFR part 820, ISO13485, ISO14971, and GDP.
• Provide process verification and validation, including IQ, OQ, PQ, and TMV.
• Conduct root cause analysis and participate in CAPA processes.
• Identify critical product features and interpret engineering drawings and GD&T.
• Maintain risk management processes across products and processes.

Minimum Requirements

• Bachelor’s Degree
• 4 years relevant experience or advanced degree with 2 years relevant experience

Preferred Qualifications

• Degree in Engineering, Science, or related field
• Masters or PhD in Engineering, Material Science, or Chemistry
• Experience in regulated industries and medical devices
• Strong skills in test method development, validation, and quality engineering
• Knowledge of medical device regulations and standards
• Experience with inspection tools, QAD, SAP, and Six Sigma/ASQ certifications

Physical Requirements

Physical demands are representative of those required to perform the essential functions of the role. Reasonable accommodations will be made for qualified individuals with disabilities. Regular mobility, computer skills, and communication with colleagues are necessary.

Compensation and Benefits

Salary range: $96,800 - $145,200 (USD). Eligible for incentive plans, comprehensive health benefits, 401(k), paid time off, and more, depending on location and employment status.

About Medtronic

Medtronic is a global leader in healthcare technology, committed to alleviating pain, restoring health, and extending life. Join our team of over 95,000 dedicated employees working to develop innovative solutions for real-world health challenges.