Quality Engineer II

Engineering             ·            Memphis, Tennessee, United States             ·          Full time

Locations: Memphis, Tennessee, United States

Job ID: 230007DV

Job Description

Careers that Change Lives 

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.

Join a Culture of Collaboration and Innovation.

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 primarily support post market surveillance activity for Medtronic’s intelligent data solutions (iDS) business, but provides exposure and opportunity across the CST operating unit. 

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.
• US and International travel requirement: Less than 10%

Must Have: Minimum Requirements

• Bachelors degree in Engineering, Science, or technical field with minimum of 2 years of relevant experience required
•  Or advanced degree with 0 years of experience

Nice to Have

• Strong technical writing and verbal communication skills
• Experience with software programs preferred – Microsoft Word, PowerPoint, Excel, and Minitab.
• Internship or experience in medical device or regulated industry

Knowledge of quality tools and approaches:

• Risk analysis
• Root cause analysis
• Problem solving approaches

About Medtronic

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. 

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 or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

Min Salary: 72,000
Max Salary: 108,000
Travel: Yes, < 25 % of the Time

Please click here to apply.