Senior Supplier Quality Engineer - Hybrid at Medtronic in Brooklyn Center, Minnesota

Job Description:

We anticipate the application window for this opening will close on - 25 Nov 2024

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
In this exciting role as a Sr. Supplier Quality Engineer, you will be responsible for the management of our strategic Contract Manufacturers (CMs) and Original Equipment Manufacturers (OEMs) at Medtronic, with accountability to support changes to existing supplied products and processes, as well as oversight of performance and improvement activities. While partnering with our CMs and OEMs, including sub-tier suppliers as required, this position is responsible for maintaining necessary controls and drive improvements relating to finished medical device / component quality in conjunction and within our suppliers' quality systems.

You will work in partnership with the internal Medtronic R&D, Quality, and Regulatory teams, to ensure our supplied products conform to finished device requirements, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products while staying in compliance to applicable industry standards, regulatory requirements, and customer requirements.

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.

• Ensures that suppliers deliver quality parts, materials, and services.


• Work with Medtronic's strategic CM/OEM suppliers to lead and drive systematic approaches to medical device quality issues.


• Coordinate and monitor change control process (including review and approval) to ensure performance, compliance and regulatory requirements are met and properly documented.


• Oversee changes to processes/products currently in production to aid in the correction of process, design or material problems (as well as changes associated with sub-supplier and material changes). Lead quality process improvements and streamlining activities.


• Review/prepare test plans and reports (qualification, validation) for change and improvement activities (supplier certifications, material/sub-supplier changes and supplier performed special processes); leveraging the Production Part Approval Process (PPAP) when required.


• Work with sub-tier suppliers, as required, to lead and drive systematic approaches and ensure stability related to medical device quality.


• Ensure the resolution of all issues raised during testing/qualification.


• Drive corrective/preventative actions at our CMs/OEMs based on feedback from incoming inspection, production defects, Medtronic/supplier internal quality metrics and customer complaints.


• Supports Corporate and external (FDA, TUV, BSI, etc.) quality and compliance audits of the CM/OEM products and/or the supplier's Quality Management System.


• Provide statistical support by the creation of supplier related metrics for the purposes of tracking vendor performance and identifying opportunities for supply chain improvements.


• Support / Lead sustaining engineering projects that may involve manufacturing process transfers, label/IFU updates, sub-supplier qualification, performance testing (verification and validation), and design qualification.


• Participate in the audit/assessment of current or future suppliers/contract manufacturers ensuring they are compliant with associated Medtronic policies and GMP/ISO requirements.

Must Have: Minimum Requirements

• Bachelor's degree required


• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience

Nice to Have

• Medical device manufacturing industry experience, preferably to ISO 13485, 21 CFR 820, and ISO 14971


• Experience with executing PPAP (Production Part Approval Process) for plastic injection molding and/or electronic commodities; including enforcing requirements in IQ/OQ/PQ, Process Validation, pFMEA and Risk Assessments of suppliers, Test Method Validations, and Measurement System Analysis


• Accomplished in performing CAPA investigation, as well as Supplier-related NCMRs and Complaints


• Advanced knowledge of working with Contract Manufacturers or Original Equipment Manufacturers; including Supplier Maintenance and Controls, Supplier Audits, Quality Agreements, and Quality Performance Reviews


• Adept in Supplier Change Process evaluation and implementation, including working with sub-tier suppliers


• Failure investigation techniques, statistical quality controls, protocol & report preparation, and non-conforming product controls


• First Time Quality Coach (FTQ) / Six Sigma / DFSS / Lean Yellow Belt, Green Belt or Black Belt certified


• ASQ CQE, CQA and/or CSQP certification


• Ability to manage tasks and projects under tight deadlines with a sense of urgency.


• Strong communication and presentation skills, with the ability to confidently address external audiences and high-level leadership.


• 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.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

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.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$94,400.00 - $141,600.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 90,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here .

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.