Prin Supplier Qual Engineer at Medtronic in Minneapolis, Minnesota

Job Description:

Careers That Change Lives

As a Pr. Supplier Quality Engineer, Pre-Market, you will provide 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 complex components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements

Cardiac Ablation Solutions

CAS provides a broad suite of electrophysiology solutions intended to disrupt and lead the market in cardiac mapping and ablation technologies for arrhythmia management. These clinical and economical solutions will enable clinicians to treat patients with safer, faster and easier, and with more predictable procedure times and outcomes

A Day in the Life

As a member of Supplier Quality, you will be responsible for partnering with Development Engineering and Sourcing to identify, develop, qualify and release to manufacturing cost effective complex components/materials for use in Medtronic Devices. In this area of new product development, you will be required to drive multiple aspects of complex component/material development and approval with suppliers as a member of a cross-functional team.

• Drive supplier requirements by collaborating with Development Engineering and other cross-functional partners to clarify design intent, identify critical features, and assess feature risk. Partner with suppliers to ensure components are designed for reliability, manufacturability, and cost.
• Define component qualification strategy, partner with suppliers to develop qualification plan, report performance, and demonstrate release readiness
• Perform process and component/material development work with suppliers to deliver highly capable components/materials. Applies principles of chemistry, physics and material behaviors in the development of supplier processes.
• Support project deliverables, supply risk reduction, yield improvement and cost reduction activities during development
• Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD

• Develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
• As a Principal level engineer, you may be mentoring and coaching lower level team member.

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

Requires a Bachelor of Science in Mechanical Engineering, Chemical Engineering, Material Science, or similar discipline. and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience. Preferred Education: Master of Science in Engineering

Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.

May have broad knowledge of project management.

Experience with Supplier processes

Applied knowledge of DOE, SPC, FMEA, Gage R&R, Basic Statistics

Demonstrated technical writing skills

Proficient in MS Office - MS Project focus

Experienced with inspection equipment and material testing processes

Capable of coordinating cross functionally with groups such as Design Engineering, Sourcing, Commodity management, and Quality to resolve issues and provide status of assigned activities.

Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485

Nice to Have

• 7+ years of supplier quality engineering experience in the medical device industry or related field with supplier quality management expertise.
• ASQ CQE and lead auditor certification
• Demonstrated expert knowledge of supplier controls, process validation, supplier and internal auditing, failure investigation techniques, statistical quality control, protocol/report preparation and non-conforming product controls
• Advanced use and understanding of statistical tools including DOEs
• PPAP expert
• Recognized expert, managing large projects or processes.
• Lean Sigma or DRM Black Belt certification to be able to develop solutions to complex problems, and makes significant improvements of processes, systems or products independently to enhance performance of job area.
• Excellent communication skills; both written and oral, internal and external to the company.
• Recognized expert in Understanding of material properties and how they can be impacted by Supplier processes.
• Expert knowledge of measurement systems and Supplier processes (EDM, CNC, Laser, Chemical, Plasma, Stamping, Milling, Polymer Processing, Molding, Extrusion, etc manufacturability, assembly, and process control.
• Master ANSI Y14.5M requirements (GDT)

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)

Travel up to 25% of the time