Medtronic Principal Supplier Quality Engineer in Irvine, California
Principal Supplier Quality Engineer
Irvine, California, United States
Sep 21, 2021
Careers That Change Lives
A career at Medtronic is like no other. Were purposeful. Were committed. And were driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.
In this exciting role as a Principal Supplier Quality Engineer you will have responsibility for defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results. Manage large projects or processes. Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation. Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
Performs qualification audits of new suppliers to ensure good manufacturing practices (GMP) and quality standards are met.
Evaluates suppliers internal functions to assess their overall performance and provides feedback in assessment of their operation.
Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.
Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.
Performs Component Qualification (Process Characterization, Process Capability Analysis, Test Method Validation, IQ, OQ, PQ, FAI) of new supplier manufactured components as part of NPD projects.
Deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.
Mentors engineers on team on Supplier Quality Engineering methods.
Recommends equipment and process modifications for Suppliers to meet quality standards and improve process capability manufacturing techniques.
Reviews product development requirements for compatibility with processing methods.
Interacts with product design and development personnel and Supplier personnel to ensure that processes and designs are compatible.
Develops and conducts statistical analysis or recommends additions to document work.
Works with Supplier to develop and/or optimize new manufacturing concepts, processes and procedures. This can include scouting and feasibility work, material selection, process and equipment selection, tooling / fixture and equipment installation and assessment of inputs, outputs and alignment to requirements.
Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems.
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelors Degree in Engineering, Science or technical field with 7+ years of work experience in Engineering and/or Quality OR Masters Degree Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality.
Nice to Have (Preferred Qualifications):
Masters degree preferred
Medical device experience; or experience in a regulated environment
Experience working with suppliers and/or contract manufacturers
Strong analyt/ical skills
Excellent communication skills
Ability to work effectively within team and across functions
Ability to travel up to 50% of time (this role is not remote)
ASQ-CQE, CQA, Six Sigma Black Belt, Lean Certified or equivalent certifications
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. Lets 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)
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
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