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1+ months

Sr Principal Quality Engineer

Fridley, MN 55432
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Sr Principal Quality Engineer


Fridley, Minnesota, United States

Requisition #:


Post Date:

Feb 09, 2022

**Careers That Change Lives**

A career at Medtronic is like no other. Were purposeful. Were committed. And were driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.

In this exciting role as a **Sr Principal Design Quality Assurance Engineer** you will work as a part of the core new product development teams in Pelvic Health Operating Unit leading the collaborative design quality strategy for projects in alignment with business goals for cross-functional teams including RD/Regulatory/Marketing/Operations.

**A Day in the Life**

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

+ Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

+ Participate in review of methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.

+ Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

+ May lead as a quality core team member responsible for driving quality into the design and development.

+ Lead the collaborative quality strategy for projects in alignment with business goals for cross-functional teams including RD/Regulatory/Marketing/Operations.

+ Participate in design reviews for the product as well as review and approve design input/design output artifacts including requirements, design documents, test results, verification and validation reports, and defects.

+ Lead and conduct risk management activities including system risk analysis and input to Hazard Analysis, and FMEAs. Analyze patient safety impact.

+ Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts.

+ Review systems design, change specifications, and plans against contractual and/or process requirements.

+ Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.

+ Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.

+ Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.

+ Ensures that design changes meet acceptable reliability standards.

+ Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives.

+ As necessary, proposes changes in design or formulation to improve system and/or process reliability.

**Must Have: Minimum Requirements**

**To be considered for this role, please ensure the minimum requirements are evident on your resume.**

Bachelors Degree in Engineering, Science or technical field with 10+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 8+ years of work experience in Engineering and/or Quality

**Nice to Have**

+ Working knowledge of integrated digital health systems including consumer products such as Apple Inc./Android products.

+ Certified scrum master or SAFe or Black Belt or Green Belt or CQE.

+ Experience in a highly regulated industry, preferably implantable medical devices

+ Knowledge and experience in application of statistics and lean sigma principles

+ Demonstrated ability to work in a matrix organization and positively influence strategy and outcomes.

+ Ability to deliver on multiple projects simultaneously, and balance between long- and short-term priorities.

+ Demonstrated critical thinking skills with focus on improved system performance outcomes and positive business impact.

+ Excellent problem-solving skills, including demonstrated application of structured problem-solving methods and tools.

+ Strong written and oral communication skills. (timely, clear, concise, accurate, conclusive, influential, targeted to audience)

+ Strong collaboration and influence skills. (build relationships, leverage others, align and work towards shared outcome-based goals, understand others needs, negotiate for win-win, own the whole)

+ Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, IEC 62304, IEC 60601-1, MDD EU MDR

+ Experience in Design-Reliability-Manufacturing (DRM) or equivalent corporate design and/or manufacturing process improvement initiative

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


Posted: 2022-03-08 Expires: 2022-06-06
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Fridley, MN 55432

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