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1+ months

Sr. Risk Management Engineer

Albion, MI 49224
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Sr. Risk Management Engineer


Rice Creek, Minnesota, United States

Requisition #:


Post Date:

Oct 16, 2020

**Careers That ChangeLives**

In this exciting role as
a **Sr. Risk Management Engineer** you will have responsibility for providing
Risk Management expertise throughout the product life cycle including
development, market release, and post-market monitoring of new and derivative

The **RestorativeTherapies 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.

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

**A Day in the Life**

Responsibilities may include the following and other
duties may be assigned.

+ You will analyze designs to:

+ identify hazards inherent to design

+ Determine probability of harm due tohazards

+ Evaluate impact to patient safety

+ Quantify residual risk

+ Perform risk/benefit analysis

+ You will understand therapy (clinical) performance,product functions, and product use environments to appropriately andstrategically apply technical knowledge, risk management tools andmethodologies to drive safety improvements.

+ Maintain risk management file forproduct lifecycle, ensuring the latest knowledge on risk reflected in the riskdocumentation.

+ Actively communicate findings toQuality, Development, and Operations teams.

+ You will perform systematic riskanalysis against features, requirements, architecture, interfaces, and designs,through the appropriate application of risk management techniques (e.g. hazardanalysis, risk/benefit analysis) to understand product and process robustness.

+ Assure compliance to organizational procedures, regulatoryrequirements and industry standards, and timely completion of assigned CAPAsand audit findings.

+ You will work on organizational processimprovement projects, cross-functional business improvement teams, and developshared best practices to drive functional excellence.

+ May provide guidance, coaching, and training to other employeeswithin job area.

**Must Have: MinimumRequirements**

Bachelors Degree in Engineering, Science or technical field with 4+ years
of work experience in Engineering and/or Quality OR Advanced degree in
Engineering, Science or technical field with 2+ years of work experience in
Engineering and/or Quality.

**Nice** **to Have**

+ 2+ year Safety or Systems Engineeringexperience

+ Experience with ISO 14971

+ Experience in Medical Devices

+ Experience working in or with Design,and Operations

+ Understand therapy (clinical)performance, product function(s), and product use environments to appropriatelyand strategically apply technical knowledge, analysis tools and methodologiesto understand and quantify residual risks.

**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: 2020-10-20 Expires: 2021-04-26
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Sr. Risk Management Engineer

Albion, MI 49224

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