Pre-Market Sr. Supplier Quality Engineer- Hybrid - Brooklyn Park, MN.

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.

In this exciting role as a Senior Supplier Quality Engineer, you will have responsibility for the management of suppliers within the Cardiac Surgery premarket Quality Team, with accountability to support selection, approval and qualification of new suppliers or changes to existing supplied products and processes, as well as oversight of performance and improvement activities.

You will also lead the oversight of supplied products, ensuring conformance to purchased materials or finished devices requirements and management of nonconforming product in compliance to Medtronic Purchasing and Supplier Controls, FDA, and international requirements and Quality System Regulations.

Cardiac Surgery

Cardiac surgery represents end-state treatment in the care continuum for many cardiovascular diseases. There are approximately 1.

8 million cardiac surgical procedures in the world on an annual basis. Cardiac surgery remains extremely important in treating complex disease and remains the gold standard on which many of the other therapies being developed in Cardiovascular are based upon.

A Day in the Life

• Provides Supplier Quality Engineering support on NPD projects working in partnership with the Ops, PMO, and R&D to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.
• Represent the organization as the primary supplier technical contact, at times requiring coordination between organizations.
• Support the evaluation and selection of global best-in-class suppliers through the application of appropriate tools and measurements.
• Prepare and negotiate Quality Agreements with suppliers.
• Apply process development and materials knowledge to component development and quality issues.
• Review supplier processes and equipment for optimum output, yield and process stability.
• Recommend and drive continuous improvements in the Supplier Quality organization, to improve the related systems and processes in Medtronic.
• Provides technical guidance and quality compliance for Supplier Quality engagement to qualify new parts and implement strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance with applicable industry standards, regulatory requirements, and customer requirements.
• Delivers the Product Acceptance Sampling Strategy, Approved Supplier List updates / additions, 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.

Must Have : Minimum Requirements (To be considered for this role, please ensure the minimum requirements are evident on your resume) :

Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and / or Quality OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and / or Quality.

Nice to Have

• Bachelors or Masters Degree in Mechanical Engineering, or other related engineering degree strongly preferred.
• Experience in medical device design and application of test standards.
• Experience in application statistical methods to design reliability and process capability.
• Certified Quality Engineer, Reliability Engineer, or equivalent desired.
• Strong oral and written communication skills.
• Cross-functionally and an effective team player.
• Excellent presentation skills.
• Must be able to handle multiple tasks / projects and manage priorities accordingly.
• Working knowledge of appropriate industry standards.
• Must be able to work in a team environment and exert influence without alienating others.
• Knowledge / basic understanding of specification development, industry standards, geometric dimensioning and tolerancing (GD&T), etc.
• Knowledge with PPAP process and part / product validation and qualification.
21 days ago