Medtronic

At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress and deliver meaningful innovations

Our Purpose

In our Coronary and Renal Denervation Design Assurance Team, our purpose is to increase product development process rigor to ensure robust understanding of designs, documentation of compliance to requirements and timely, high-quality product launches that satisfy patient needs and reduce customer complaint rates.

Come for a job, stay for a career!

A Day in The Life Of:

You will work as part of the Pre-Market Design Assurance team, working closely with cross-functional partners (e.g. R&D, service, operations, clinical, marketing, and regulatory) to integrate and execute Design for Reliability (DfR) activities on new product development project to drive product safety, complaint reduction, reliability, and quality outcomes that exceed patient, customer, company, and regulatory agency expectations.

• Support defining and allocating reliability requirements and goals.

• Execute reliability demonstration strategies, reliability growth activities, and recommend 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.

• Performs reliability testing as defined by development project plans and product requirements.

• Participates in defining product reliability requirements, product use cases, and developing associated test methods.

• Assists Research and Development (R&D) engineers with new product development and design for reliability across systems (mechanical, electrical, software).

• Contributes to planning, design, development, and evaluation of the company’s products including its subassemblies, components, and packaging through effective feedback of reliability test results.

• Contributes to the review of supplier capability to support reliability characterization.

• Support Design Assurance activities e.g. risk, design verification, test development, compliance

• Apply knowledge of design control principles and quality engineering techniques throughout the product development process.

• You will contribute to the product development team and be responsible for supporting activities required to ensure development and validation of new product introduction.

• Understand risk management concepts used throughout the quality system to successfully meet FDA, ANSI/AAMI/ISO 14971:2019, and ANSI/AAMI/ISO 13485:2016 requirements.

*This position will be required to sit onsite at either 3576 Unocal Building A Santa Rosa, CA 95403 OR 8200 Coral Sea Street NE Mounds View, MN 55112 and work a hybrid schedule of 3 days onsite per week.*

Required Qualifications

• Bachelors degree

• Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience

Preferred Qualifications

• Medical device industry experience

• Experience in reliability testing of electromechanical devices controlled by embedded software preferred.

• Experience in deploying tools that measure reliability performance at the component, device, or system level, including designing, building, programming, debugging, documenting, training, and releasing such tooling.

• Experience with generating reliability metrics and summaries including Warranty Predictions (Parts Count and Reliability Block Diagram), Unreliability and Nevada charts, and Time to Failure using ReliaSoft, JMP, Minitab or equivalent software.

• Experience creating and releasing test protocols, compiling test results, and compiling and releasing the related test reports.

• Experience with Accelerated Life Testing, Risk Analysis, DFMEA, Reliability Growth, and/or Demonstration Testing

• ASQ CRE Certified

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. Let’s 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, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

Min Salary

76000

Max Salary

114000

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.