Mechanical Reliability Engineer II - Mounds View, United States - Medtronic

Medtronic Mounds View, United States

2 weeks ago

Description

Mechanical Reliability Engineer II

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.

The Cardiac Rhythm Management (CRM) Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure.

We are comprised of three businesses:

·Cardiac Pacing Therapies

·Cardiovascular Diagnostics & Services

·Defibrillation Solutions

We put people first in all we do.We remain on the leading edge of innovation to ensure that we treat more people.We excel in how we operate to deliver the best experiences for people who touch our therapies.

In this exciting role as a Mechanical Reliability Engineer II, you will have responsibility for ensuring our products exceed the safety and reliability requirements and expectations of patients, clinicians, regulators, and the business.

This position is in Mounds View, MN within the Cardiac Rhythm Management (CRM) 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 Mechanical Reliability Engineer II role. This includes, but is not limited to the following:

·Collaborates with cross-functional teams to develop and release new cardiac rhythm management products and design changes.

·Plans, leads, and integrates Design for Reliability (DfR) activities on product development projects to drive product safety, complaint reduction, reliability, and quality outcomes that exceed patient, customer, company, and regulatory agency expectations.

·Evaluates designs for potential failure modes, assesses potential hazards and harms, prioritizes safety risks, identifies appropriate risk controls, and compiles evidence to demonstrate benefits outweigh product risks.

·Defines and allocates reliability requirements and goals, develops and leads reliability demonstration strategies, manages completion of reliability growth activities, and recommends design and manufacturing updates to ensure design achieves required levels of product reliability.

·Understands legacy product performance and incorporates learnings into new product development projects.

·Develops test plans, determines statistically valid sample sizes, works with test labs to demonstrate performance, addresses test observations, statistically analyzes data, and writes test reports.

·Articulates risk management and reliability activities and conclusions in documentation, regulatory submissions, and audits.

·Performs engineering reviews of quality records for safety and reliability impact.

·Advocates for safety, reliability, and quality in design reviews and other project meetings.

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, science, or a technical discipline

·Minimum of 2 years of relevant experience, or advanced degree with a minimum of 0 years relevant experience

Nice to Have

·Implantable medical device industry experience

·Advanced degree in Engineering or suitable Clinical/Field Support, Safety or Reliability Engineering, Biomedical Engineering, Mechanical Design Engineering, or Product Development Engineering experience

·Knowledge of cardiac anatomy, physiology, and primary disease states

·Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, ISO 14971, and Hazard Analysis and Risk Analysis techniques (e.g., FTA, DFMEA, Hazard Analysis Logs, Risk Management Report & Files)

·Certification (belts) in Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Lean Sigma (DFLS), and/or robust design practices

·ASQ CRE certified

·Strong written and verbal communication skills and ability to work cooperatively and influence outcomes as part of a cross-functional team

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

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