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1+ months

Sr Quality Engineer

Plymouth, MN 55446
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Sr Quality Engineer


Plymouth, Minnesota, United States

Requisition #:


Post Date:

Jan 25, 2021

**Careers that Change Lives**

**A Day in the Life**

The Sr Quality Engineering position on the team supports new product development for the ILS Platform. In this role, the Sr Quality Engineer works as part of the quality team supporting the cross-functional core team. An understanding of mechanical design, validation, and/or design for reliability/six sigma is preferred. As an important member of our Quality Team, you will provide guidance and implement strategies that drive product quality and continuous improvement.


+ Actively participate in product development cycle by reviewing project documentation, participating in product risk assessments, and working closely with Product Development to develop appropriate verification and validation testing requirements.

+ Assesses overall product risk by facilitating the development of risk management tools such as the risk management report, failure mode and effects analyses (FMEAs), etc.

+ Collect, analyze and interpret statistical data. Performs analyses and provide reports to management as required.

+ Contributes to the successful completion of Process Validation initiatives by facilitating validation master plans and the qualification activities required to meet validation requirements. May include Process Flows, Control Plans, Design of Experiments, Measurement Systems Analyses, and Process Capability Analyses.

+ Job requires interaction with cross functionalproject team members as well as members of the QA extended team.

+ Tracking timelines and facilitating the required Quality Engineering deliverables.

+ Assisting with projects and assuring proper and consistent implementation of the quality engineering tools.

+ Provide support to other quality groups to assure efficient completion of project requirements.

+ Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.

+ Provide guidance on the principles of risk management standards as they relate to the new product development activities of mechanical medical devices

**Embedded Responsibilities:**

+ Excellent organizational and communication (oral and written) skills. Ability to work on teams as well as individually. Able to set and meet goals. Organized and detail oriented. Problem solving and analysis skills.

Statistical knowledge and Minitab experience. Demonstrated ability to document test data, analyze test results utilizing statistics, write clear and concise lab reports, and make recommendations to evaluate product.



+ B.S. degree in Engineering, Math, Physical Science, or equivalent field

+ Preferred: M.S. degree in Engineering, Math, Physical Science, or equivalent field

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


+ Minimum Experience: 5+ years of experience in a regulated industry (2 years of experience can be substituted for an Advanced degree in a related discipline)


+ Fundamental understanding of mechanical designs and manufacturing processes to support designing, troubleshooting, refining and qualifying the design to ensure the sustainable manufacturing of medical devices both internal and external.

+ Experience in a regulated industry

+ Experience with Minitab or similar statistical analysis tools

+ Good interpersonal skills; Ability to work effectively in a team environment and build strong working relationships.

+ Ability to work in a fast-paced environment; Ability to work well under pressure and maintain positive, enthusiastic attitude

+ Strong attention to detail and accuracy. Ability to successfully balance and prioritize multiple ongoing projects/tasks (Project Management skills).

+ High degree of initiative and self-motivation. Strong analytical skills and the ability to solve problems through analytical reasoning.


+ ASQ Certified Quality Engineering (CQE)

+ Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO13485, 14971 and 60601 requirements

+ Experience with Geometric Dimensional and Tolerancing (GDT) and the ability to read blueprints

+ Support reliability activities for new product development. Drive for root cause understanding and corrective action implementation to ensure product meets reliability requirements.

**Nice to Have**

**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: 2021-01-28 Expires: 2021-05-07
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Sr Quality Engineer

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