Careers that Change Lives

A Day in the Life

Provide comprehensive support to new product development teams with focus on supplier quality and design transfer activities.

Responsibilities may include the following and other duties may be assigned.

• Works effectively with colleagues in cross-functional or departmental team projects
• Makes decisions and proposes solutions based on calculated risks identified through data analysis
• Leads or assists with part approval process activities to identify and qualify suppliers for critical instrument components while adhering to corporate policies and applicable regulations
• Implement approved changes using sound quality engineering principles and fully document them in compliance with Quality System Regulation (QSR 21 CFR 820), ISO 13485 and Corporate Policies.
• Assist with protocol and implement process validation procedures in accordance with QSR, FDA and international guidelines.
• Capable of leading cross-functional projects with little or no guidance.
• Coordinate activities through the Quality Engineering Manager and report regularly on the progress of activities.
• Participate in meeting departmental goals and objectives.
• Mentor or supervise junior engineers.

Must Have: Minimum Requirements

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

Nice to Have

• Working knowledge of combination medical device products
• Effective verbal and written communication, analytical, influencing and interpersonal skills.
• Must be able to effectively communicate at all levels and across company lines as well as effectively communicate with suppliers.
• Six-Sigma greenbelt or blackbelt certification
• 5+ years of Quality Assurance experience in a QSR (GMP), disposable medical device environment
• Working knowledge of Quality System Regulation (QSR 21 CFR 820) and EU Medical Device Directive (EU MDD 93/42 EEC)
• Demonstrated working knowledge of manufacturing and supplier quality processes.
• PC skills, word processing, spreadsheets, project management, etc.

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. Learn more about our benefits here .

This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) on page 6 here .

The provided base salary range is used nationally (except in certain CA locations).The rate offered is compliant with federal/local regulations and may vary by experience,certification/education, market conditions, location, etc.

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, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)