Reliability Engineer – Neuromodulation

Location:

Fridley, Minnesota, United States

Requisition #:

17000NJC

Post Date:

6 days ago

**Reliability Engineer – RTG Neuromodulation**

The **Reliability Engineer** focuses on aspects of product quality and reliability for products that are in the field . In this role, you will provide risk and reliability engineering support for design and process changes. You will also analyze the risk of non-conformances for products in the field and the risk of trends in complaint data. The Reliability Engineer ensures that analysis meets acceptable reliability standards and that documentation is compliant with requirements.

You may specialize in the areas of design, incoming material, production control, product evaluation and reliability, as they apply to product or process reliability.

**A Day in the Life / Responsibilities:**

•Evaluate reliability impact of proposed design and manufacturing changes on existing market released product.

•Conduct analysis of field performance of existing product.

•Perform statistical analysis of data for risk of issues with product in the field.

•Review of proposed process change requests for potential impact on product reliability and testing needs required to support the change.

•Prepare plans, reports, and presentations as necessary to support project teams.

•Present data/presentation material to staff, clients and customers as required.

•Work on process improvement projects.

•Lead improvement teams.

•Prepare reports intended for submission to regulatory agencies for review and consideration of approval for product changes.

•Review Engineering Change Requests for product impact on reliability.

•Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high quality work.

•Demonstrate familiarity with regulatory requirements (e.g. ISO 13485, 12CFR820, EN ISO 14971).

•Prioritize and manage multiple priorities effectively with minimal direction.

•Working knowledge of problem solving and statistical methods as applied to process and product quality and reliability.

•Participate in technical design reviews, project phase reviews, change control reviews.

•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.

•Follow all Quality System Practices as defined by Medtronic RTG practices, policies and Standard Operating Procedures to ensure that FDA, ISO and European Medical Device quality standards and regulations are met where applicable.

•All activities must be performed in compliance with the Quality System.

•Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.

•All other duties as assigned.

**Medtronic RTG (Restorative Therapies Group) Overview**

The **Restorative Therapies Group** 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.

**PAIN THERAPIES** offer solutions — from early interventional procedures to implantable surgical technologies — that treat chronic pain as well as pain from spinal fractures, cancer and severe spasticity.

**SPINE THERARIES** shape spine surgery for the better; delivering procedural solutions and therapeutic biologics and partnering with other healthcare stakeholders to accelerate innovations that can improve surgical efficiencies and help create better outcomes for more patients.

**BRAIN THERAPIES** offer an integrated portfolio of devices and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improvethe precision and workflow of neuro procedures.

**SPECIALTY THERAPIES** offer a broad portfolio that addresses urologic and gastrointestinal disorders, conditions of the ear, nose and throat, as well as electrosurgical products for soft tissue dissection and hemostatic sealing of soft tissue and bone.

**_Come for a job. Stay for a career._**

**Must Have: Minimum Requirements**

+ Bachelor’s degree in Electrical Engineering, Biomedical Engineering, Mechanical Engineering, or Computer Science that includes background in Numerical Methods

+ 2+ years of engineering experience in a mechanical or electrical technical role in addition to Bachelor’s degree

**Preferred experience:**

•Working knowledge of FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971, WEEE, RoHS, and IEC 60601 standards.

•Knowledge of statistical techniques and reliability tools. Proficient with data analysis.

•Knowledge of Wiebull Analysis, DOE techniques.

•Highly developed skill set in project leadership practices including ability to balance risk, effectively influence diverse teams, and ownership of responsibility for outcomes.

•Excellent downward, lateral, and upward communication skills.

•Good balance of high level strategic and detailed tactical thought processes.

•Demonstrated track record of successfully leading projects to completion.

•ASQ certification.

•Formal training in Six Sigma methods combined with project deployment experience at the green belt or greater level is highly desirable.

•Well-developed oral and written communication skills.

•Experience working with cross-functional teams.

•Previous experience in managing multiple projects having multiple tasks.

•Facilitate standardized process for trending, risk assessment, and statistical analysis.

**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.

+ 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.

**RTG (Restorative Therapies Group) Overview**

The **Restorative Therapies Group** 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.

**PAIN THERAPIES** offer solutions — from early interventional procedures to implantable surgical technologies — that treat chronic pain as well as pain from spinal fractures, cancer and severe spasticity.

**BRAIN THERAPIES** offer an integrated portfolio of devices and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improvethe precision and workflow of neuro procedures.

**SPINE THERAPIES** shape spine surgery for the better; delivering procedural solutions and therapeutic biologics and partnering with other healthcare stakeholders to accelerate innovations that can improve surgical efficiencies and help create better outcomes for more patients.

**SPECIALTY THERAPIES** offer a broad portfolio that addresses urologic and gastrointestinal disorders, conditions of the ear, nose and throat, as well as electrosurgical products for soft tissue dissection and hemostatic sealing of soft tissue and bone.

**ABOUT MEDTRONIC:**

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 can 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.

**EEO STATEMENT:**

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.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees

**DISCLAIMER:**

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

**_Come for a job. Stay for a career_** .

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