Principal Supplier Quality Engineer

Medtronic•Minneapolis, MN

10d•$120,000 - $180,000

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life 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 Principal Supplier Quality Engineer , you will have responsibility for management of supplier transfers within the Global Supplier Quality Supplier Change Implementation Team. Y ou will have responsibility for and authority to provide Quality Assurance Engineering representation to select business teams facilitating front-end design, design transfer to manufacturing, and process improvements to obtain optimum product reliability, safety, and effectiveness. Coordinate feedback of quality indicators and statistics to business team for use in business decisions. Perform, direct, or consult in supplier validations. QA approvals for Engineering Change Notices, test methods, and test equipment to assure the design and production of medical devices are in compliance with applicable standards. Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs. Responsibilities may include the following and other duties may be assigned. Define component qualification strategy (PPAP), partner with suppliers to develop qualification plan, report performance, and demonstrate release readiness. Author or review key component engineering lifecycle deliverables throughout product development, as defined by procedures. Define control plans to ensure appropriate acceptance activities. Execute Product Qualification activities ensuring suppliers are capable of delivering quality products and materials. Provides technical guidance and quality compliance for Supplier Quality engagement throughout the Product lifecycle. Execute Product Acceptance Strategy and associated test method validation at suppliers. Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation. Develops and delivers the Product Acceptance Sampling Strategy, Approved Supplier List coordination, and Supplier Owned Quality deployment for transferred products.

Requirements

Requires a Bachelors degree in Engineering, Science or Technical field and minimum of 7+ years of relevant experience OR Master's degree with a minimum of 5+ years relevant experience OR PhD with 3+ years relevant experience.

Nice To Haves

Requires mastery level knowledge of specialty area and working knowledge of several other areas, typically obtained through advanced education combined with experience.
May have deep knowledge of project management.
Supplier Controls process knowledge and experience, including creation and maintenance of supplier files in the approved supplier list (ASL)
Experience in Windchill and Agile PLM systems
Working knowledge of FDA regulations and ISO standards applicable to implantable and non-implantable medical devices
ASQ CQE, CQA and/or CSQP certification
First Time Quality Coach (FTQ) / Six Sigma/ DFSS / Lean Green Belt or Black Belt certified
Knowledge with PPAP process and part/product validation and qualification
Strong knowledge of metrology & measurement techniques; statistical analysis (e.g. Ppk/Cpk, standard deviation, correlation) in Minitab, measurement uncertainty, GD&T, Gauge Repeatability & Reproducibility
Demonstrated track record of effectively influencing and negotiating with suppliers and leading effective/successful change initiatives
Skilled in project leadership practices, including ability to balance risk and benefit, effectively influence diverse teams, and ownership of responsibility for outcomes.
Excellent downward, lateral, and upward communication skills
Strong organizational and presentation skills
Good balance of high level strategic and detailed tactical thought processes
Strong competencies in judgment and problem solving (especially root cause analysis)

Responsibilities

Define component qualification strategy (PPAP), partner with suppliers to develop qualification plan, report performance, and demonstrate release readiness.
Author or review key component engineering lifecycle deliverables throughout product development, as defined by procedures.
Define control plans to ensure appropriate acceptance activities.
Execute Product Qualification activities ensuring suppliers are capable of delivering quality products and materials.
Provides technical guidance and quality compliance for Supplier Quality engagement throughout the Product lifecycle.
Execute Product Acceptance Strategy and associated test method validation at suppliers.
Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
Develops and delivers the Product Acceptance Sampling Strategy, Approved Supplier List coordination, and Supplier Owned Quality deployment for transferred products.

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)