Careers that Change Lives

A career at Medtronic is like no other. We're purposeful. We're committed. And we're driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.

Part of the Neuroscience portfolio, Cranial and Spinal Technologies is comprised of four global businesses: Spine & Biologics, Enabling Technologies, and China Cranial, Spinal, Orthopedics & Technologies.

• Spine & Biologics, offers procedural solutions for spine surgery, and bone grafting solutions for spinal fusion.
• Enabling Technologies, delivers an innovative portfolio which include robotics, navigation, intra-operative imaging, advanced energy devices, cerebral spinal fluid management and critical care.
• China Cranial, Spinal, Orthopedics & Technologies, provides solutions in spine surgery, neurosurgery, surgical synergies, biologics, and orthopedics.

A Day in the Life

In this exciting role as a Quality Engineer II, you will support post market quality activity including risk evaluations, product trending and signal evaluation, complaint investigations, and surveillance reporting for the Cranial and Spinal Technologies (CST) operating unit. This role will support post market surveillance activity for Enabling Technologies products and provides exposure and opportunity across the CST operating unit. Working in this position will frequently leverage engineering skills, critical thinking, clear communication (both verbal and written), and thoughtful prioritization of various business needs relating to post market product quality.

ESSENTIAL FUNCTIONS:

• Provide quality engineering support or process ownership for global post market surveillance processes specifically focusing in the areas of product investigations, complaint investigations, escalated issue investigations, and post market surveillance plans and reports.
• Define and maintain statistical thresholds for complaint monitoring. Execute post market trending process.
• Collaborate with cross-site Post Market Quality, Regulatory Affairs, and Engineering to support and author pre- and post-market product risk assessments.
• Provide support in completing returned product analysis and investigation.
• Ensure post market surveillance processes maintain regulatory compliance including supporting MDR, MDD, and EUMDR required activities for post market surveillance.
• Provide support for Corrective and Preventive Actions (CAPA).
• Supports business initiatives for process improvement.
• Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
• Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.
• All other duties as assigned.

Must Have: Minimum Requirements

• Bachelors degree on Engineering, Science, or tec related field required
• Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience

• Strong technical writing and verbal communication skills.
• Knowledge of FDA quality system regulations, including 21 CFR 820.
• Experience with software programs preferred - Microsoft Word, PowerPoint, Excel or Minitab.
• Knowledge of quality tools and approaches including CAPA, failure analysis and root cause analysis.
• Problem solving approaches and experience with Medical devices that incorporate software is beneficial.

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here .

This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here .

The base salary range is applicable across the United States, excluding Puerto Rico. Base pay is based on numerous factors and may vary by job-related knowledge, skills, experience, etc. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)