Senior Reliability Engineer

Found in: Talent US C2 - 1 week ago

Grand Rapids, United States Medtronic Full time

Senior Reliability Engineer 

Careers That Change Lives 

At Medtronic, we push the limits of what technology can do to make tomorrow better than yesterday and that makes it an exciting and rewarding place to work. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. 

In this exciting role as a Senior Reliability Engineer supporting the Cardiac Surgery Post Market Quality organization, you will have responsibility for supporting Post Market Surveillance, Risk Management, and complaint investigationsassociated with the integration of the Medtronic Grand Rapids, MI. site.

The Cardiac Surgery Operating Unit develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.

This position is in Grand Rapids, MI. within the Cardiac Surgery (CS) Operating Unit and requires on-site presence three days a week.

We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.

A Day in the Life

In general, the following responsibilities apply for the Senior Reliability Engineer role. This includes, but is not limited to the following:

·Supports Reliability Engineering Integration Activities in support of the Medtronic Grand Rapids site.

·Completes risk assessments to investigate and confirm the impact of quality issues for potentially affected product in the field.

·Supports engineering changes, executing reviews as a released Design Quality approver.

·Reviews and trends coding to events to capture findings.

·Collaborates with cross-functional teams to support timeliness metrics and complete in-depth investigations from field signals.

·Responsible for the completion of risk management documentation updates and maintenance.

·Supports risk analysis studies of design and processes, including both existing design remediation and new design, as required.

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

·Ensures that corrective measures meet acceptable reliability standards.

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

·May develop mathematical models to identify units, batches or processes posing excessive failure risks.

·As necessary, proposes changes to improve systems and/or processes.

Must Have - Minimum Requirements

TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME

·Bachelor’s degree required in engineering, math, statistics, or a technical discipline

·Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience.

Nice to Have

·Medical Device Industry experience.

·Strong written and verbal communication skills and work cooperatively as part of a team and cross functionally.

·Ability to manage project timelines to execute deliverables in a timely manner.

·Ability to solve problems and innovate solutions.

·Quality experience working in a regulated industry.

·Knowledge of Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS.

·Experience working within complaint management system.

·Familiarity with these regulations: FDA 21 CFR Part 820 cGMP, ISO 13485, ISO 10012, and ISO 17025.

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