Principal Supplier Quality Engineer - Nathan Lane (on-site)

$114,400 - $171,600/Yr

Medtronic - Plymouth, MN

Full-time - Senior

Plymouth, MN

Professional, Scientific, and Technical Services

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. In this exciting role as a Principal Supplier Quality Engineer you will have responsibility for management of suppliers within the Plymouth (Nathan Lane, on-site), MN SQE team. You will be accountable for 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. Peripheral Vascular Health therapies treat patients with Peripheral and Carotid Artery Disease, End-Stage Renal Disease, Superficial and Deep Venous Diseases, and a variety of conditions treated with Peripheral Embolization. The operating unit leads the way in the Superficial Venous, Deep Venous Stenting, AV Access and Drug-Coated Balloon markets, caring for over 1 million patients globally with lifesaving and life-enhancing therapies. 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

• Ensure that suppliers deliver quality parts, materials, and services.
• Lead cross-functional teams of engineers and manufacturing functions to investigate and resolve supplier-related quality or compliance issues discovered during incoming inspection.
• Lead and/or participate in corrective/preventive action teams in resolving supplier-related issues (e.g., nonconformances, CAPA activities, audit findings, complaint investigations, etc.).
• Coach team members on supplier quality principles, quality system requirements, statistical analysis, and application of technical analysis to daily assignments.
• 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.
• Evaluate and act as a lead in processing and approving supplier change requests.
• Qualify suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
• Monitor parts from acquisition through the manufacturing cycle and communicate and resolve supplier-related problems as they occur.
• Evaluate suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
• Provide technical guidance and quality compliance for Supplier Quality engagement throughout the product's lifecycle.
• Develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for existing products.
• Formulate, deliver and/or manage projects assigned and works with other stakeholders to achieve desired results.
• Support internal and external audit and inspections, including preparation and resolution of audit and inspection findings.
• Collaborate cross-functionally with internal stakeholders and interact with multiple levels of personnel internally and externally to ensure timely completion and approvable output of Supplier CAPA records.

Requirements

• Bachelors degree in Engineering, Science or technical field.
• 7+ years of relevant Quality and/or Engineering experience in a manufacturing environment, OR Advanced degree with 5+ years of relevant Quality and/or Engineering experience in a manufacturing environment.

Nice-to-haves

• 7+ years of supplier quality engineering experience in the medical device industry or related field with supplier quality management expertise.
• Experience with catheter manufacturing, polymer (extrusion, injection molding), metal precision processing, and adhesives for the Catheter/Disposable SQE position.
• Medical device manufacturing industry experience, preferably ISO 13485.
• ASQ CQE, CQA and/or CSQP certification.
• First Time Quality Coach (FTQ) / Six Sigma/ DFSS / Lean Green Belt or Black Belt certified.
• Working knowledge of statistical methods associated with six sigma and quality control.
• Working knowledge of Quality System Regulation (QSR) 21 CFR 820 and ISO 13485.
• Lead auditor experience.
• Hands-on experience with SAP, Trackwise, Agile change management.
• Ability to manage tasks and projects under tight deadlines with a sense of urgency.
• Strong written and verbal communication skills in the English language.
• Ability to maintain a professional and respectful relationship with coworkers and company.
• Comfortable navigating through complex networks with diplomatic approaches and reporting to a flattened organization.
• Equipped with sophisticated problem-solving methodologies (Lean/Sigma) and great attention to detail to fit for fast-accurate action-driven environments.
• Engage in changes and advocate for inclusions/diversity.
• Demonstrated working knowledge of supplier controls, process validation, supplier and internal auditing, failure investigation techniques, statistical quality control, protocol/report preparation and non-conforming product controls.
• PC skills, MS Office (Word, Excel, PowerPoint and Project).

Benefits

• 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)