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

People-centered, data-driven, connected. We’re solving the world’s biggest health challenges with healthcare technology. We fuse technology and research for groundbreaking solutions. From less-invasive surgery that minimizes a patient’s downtime to the world’s smallest pacemaker, our technology transforms lives.

Engineers are indispensable to achieving our Mission. That’s why we empower you to bring the best of your experience to bear on our market-leading portfolio of innovations. Apply your existing skills and develop new ones, with the training, mentorship, and the guidance you need to continue to develop your expertise.

Join us as a valued team member at one our newest Manufacturing sites inGrand Rapids, MI where we are seeking ahands-onSenior Supplier Quality Engineer.  This site supplies Medtronic with some 600 finished products for our Cardiac Surgery (CS) portfolio – most notably Cannulae and Beating Heart products.

As the Sr. Supplier Quality Engineer, you will:

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

• 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 communicates and resolves supplier-related problems as they occur.

• Develop and prioritize an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.

• Evaluate suppliers’ internal functions to assess their overall performance and provides feedback in assessment of their operation.

• Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.

• 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 components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.

• Collaborate with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, 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

Bachelor’s Degree and 4 years of relevant experience OR advanced degree with a minimum of 2 years relevant experience.

Nice to Have:

• 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.

• 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 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.

• Engage in changes and advocate for inclusions/diversity.

• Preference given to master’s degree in mechanical, Biomedical, or Manufacturing Engineering, Engineering Technology or related engineering field, and two (2) years’ experience as a supplier, quality, or manufacturing engineer or related occupations.  OR bachelor’s degree in mechanical, Biomedical, or Manufacturing Engineering, Engineering Technology, or related engineering field, and five (5) years’ experience as a supplier, quality, or manufacturing engineer or related occupations.

• ASQ CQE, CQA and/or CSQP certification

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

• Possess a minimum of 2 years’ experience with each of the following:  

  • Supplier Change Process evaluation and implementation

  • CAPA, Supplier related Product and Process NCMR

  • Supplier Maintenance and Controls, Supplier Audits, Quality Agreements, and Quality Performance Reviews.

  • Supplier and component qualifications and validations, including Control Plans, PPAP, RIR, Gage R&R, DOE, and GD&T

  • IQ/OQ/PQ, Process Validation, pFMEA and Risk Assessments of suppliers, Test Method Validations, and Measurement System Analysis.

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

  • GMP for Class II and Class III medical devices.

  • FDA QSR 21 CFR 820, EU MDD 93/42 EEC, ISO 13485, ISO 9001 & ISO 14971.

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 - $141,600.00This 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.

At Medtronic, most positions are posted on our career site for 3-7 days.