Principal Quality Engineer

Careers that Change Lives

We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide. Come strengthen your specialized skills and enhance your expertise. We’ll support you with the training, mentorship, guidance, and networks you need to advance, and empower you to work in the way that’s best for you.
Together, we can confront the challenges that will change the face of healthcare. Join us for a career that change lives. Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.

In this exciting role asPrincipal Quality Engineer you will be focuses on minimizing materials of concern and the environmental footprint of products and packaging throughout the product lifecycle including design, manufacture, sale, change management, consumer use and end of product life. It leverages lifecycle thinking, eco design, product/packaging end-of-life solutions, and recyclability to meet regulations and customer requirements.

A Day in the Life

As a principalQuality Engineer , you will:

·Responsibilities may include the following and other duties may be assigned .

• Ensure availability of product composition information including hazardous or restricted substancesto identify safety data and labeling requirements compliance.
• Enhance business understanding, use of, and access to the centrally maintained Medtronic MoC List to meet regulatory requirements for product development, product change management, product packaging, regulator and customer requirements and business use.
• Clearly define expectations for meeting requirements and improve communication, training and tools for business sustainability design practices and risk management.
• Increase business use of EHS&S evaluation tools in earliest stage development for product design and change management to address restrictions and limitations.
• Centrally maintain completed documentation and related product content for business needs and compliance.
• Establish and monitor business level plans and programs that address end of life product disposal and recycling.
• Colloborate with suppliers and obtain material composition/material of concern information through supplier declarations and/or testing.
• Actively monitor regulatory and industry Materials of Concern requirements and incorporate updates into Medtronic Materials of Concern (MoC) List.
• Development and management of Safety Data Sheets and Labels for compliance requires product composition analysis and access to final product content materials.
• Centrally maintain Safety Data Sheet documentation for all products and improve access to controlled documents for business use and in response to regulator requests and reviews.
• Establish and monitor business level plans and programs that address end of life product disposal and recycling.
• Creating data base templates and collating the data .
• Colloborate with supplier and sub-tier suppliers, as required, to lead and drive systematic approaches and ensure stability related to medical device quality.
• Builds a collaborative relationship with suppliers to quickly address any non-conformances.
• Should be able to perform material testing and verification.

Must Have: Minimum Requirements

• Bachelors degree in Engineering, Science, or Technical Discipline required and Minimum of 15+ years of quality systems experience.
• Strong communication skills, both oral and written.
• Ability to comprehend principles of engineering, physiology and medical device use.
• Previous customer-facing and/or project management experience is a plus.
• Comfortable working with international and multi-cultural department and groups in different time zones . 
• Accurate and delivers quality work, with a sense of urgency.
• Ability to work well under pressure and maintain positive, enthusiastic attitude.
• Ability to work in a fast-paced environment .Eagerness to learn and expand responsibilities & accountablity .
• Should be able to use Solid work, CREO,CAD tools flawlessly ,understand the drawings and the Bill of materials.
• Overview on the standards like REACH, RoHS, California P65 & WEEE etc.
• Understanding of 2D drawings per ASME Standards with sound knowledge on GD&T.

Nice to Have

·Previous experience working with global team (Aerospace,Defence, Med device, automobile preferably).

·ASQ Quality certification.

·Hand on experience on Minitab tools .

·Exposure in auditing toFDA Quality System Regulation & ISO 13485.

Lean Six Sigma Green Belt or Black Belt
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)