Senior Safety and Mechanical Reliability Engineer - CRM
MedtronicAbout the role
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
Senior Safety and Mechanical Reliability EngineerCareers 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 Senior Mechanical Reliability and Safety Engineer, you will have responsibility for ensuring our products exceed the safety and reliability requirements and expectations of patients, clinicians, regulators, and the business.
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.
This position is in Mounds View, MN. within the Cardiac Rhythm Management (CRM) operating unit. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We are working on-site 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects.
A Day in the Life
In general, the following responsibilities apply for the Senior Mechanical Reliability and Safety Engineer 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.
Qualifications –
Must Have - Minimum Requirements
TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME
- Bachelor’s degree in Science, Technology, Engineering, Math or related technical discipline and a minimum of 4 years of experience OR a Master's degree with a minimum of 2 years technical experience
- One or more of following qualifications:
- Medical Doctor with related device experience
- Engineer who has achieved IBHRE Exam certification
- Personnel with at least 5 years of previous clinical experience related to cardiac implantable products
- Personnel with at least 5 years of clinical field experience in the pas
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