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Sr Reliability Engineer

Minneapolis, MN 55405
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Sr Reliability Engineer


Fridley, Minnesota, United States

Requisition #:


Post Date:

Feb 14, 2022

**Senior Reliability Engineer**

**(Rice Creek East) Fridley, MN**


**Careers that Change Lives**

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

**Medtronic Neuromodulation** delivers innovative therapies and solutions for neurological diseases, pain, and spasticity.

**Day in the Life - Responsibilities**

+ Collaborate with different departments across the organization to understand and review data to assess the patient/user risk associated with a product nonconformance, complaint, design, or manufacturing change.

+ Participate in the identification, assessment, and disposition of software anomalies.

+ Assess risks that were not previously identified, as well as potential risks associated with a market released product.

+ Provide reliability support for embedded firmware products, health software products as well as distribution of health care software products.

+ Collaborate with Medical Safety to review and analyze field data, discuss the harm severity sources, and estimate the probability or harm occurrence.

+ Author product level risk documentation with traceability for risk management files describing status of risk controls/mitigations.

+ Determine if risk management files need to be reviewed and updated.

+ Represent the organization as a technical contact for risk and reliability for processes such as: Non conformances, Anomaly Dispositions, Deviations, Complaint Formal Investigations, Change Control and CAPA among others.

+ As necessary, participate in Software Hazard Assessment (SHA) for therapy devices, clinician and patient programmers, and product instruments.

+ May perform benefit-risk analysis for medical product and/or system.

+ Provide design input to new product development for health care software and embedded software systems.

+ Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.

+ Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.

+ Completes risk analysis studies of new design and processes.

+ 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.

**Must Have: Minimum Requirements (Must be evident on your resume)**

+ Bachelors Degree in Engineering, Science or technical field with

+ 4+ years of work experience in Engineering and/or Quality


+ Advanced degree in Engineering, Science or technical field with

+ 2+ years of work experience in Engineering and/or Quality.


+ Bachelors Degree in Electrical Engineering, Biomedical Engineering, Mechanical Engineering or related science.

+ Experience with Software Application or Embedded Software development and testing.

+ Experience in medical devices or other highly regulated industry such as defense or automotive.

+ Experience in quality, reliability, design assurance, safety, or systems engineering.

+ Experience with and knowledge of medical device standards including ISO 13485, ISO 14971 (risk mgmt.).

+ Formal training in quality tools (Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, Root Cause Analysis, FMEA, FTA, DOE, etc.)

+ Demonstrated ability to work effectively and collaboratively in a team environment and build strong working relationships

+ Ability to work in a fast-paced environment; ability to work well under pressure and maintain positive, enthusiastic attitude

+ Ability to lead cross-functional teams and drive discussion and decision-making. This includes facilitation, consensus building and conflict resolution.

+ Strong written and oral communication skills including presentation skills

+ High degree of initiative and self-motivation

+ Strong attention to detail and accuracy

+ Excellent organization skills: ability to successfully balance and prioritize multiple ongoing projects/tasks

+ Strong analytical skills and the ability to solve problems through analytical reasoning.

+ ASQ Certification in Quality or Reliability is a plus.

+ Experience in the design, maintenance, or continuation engineering of software or software systems, including mobile applications is a plus.

**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. Lets 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 or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
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.


Posted: 2022-03-08 Expires: 2022-06-06
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