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Sr Quality Engineer / EMC Risk Management

Boulder, CO 80305
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Sr Quality Engineer / EMC Risk Management


Boulder, Colorado, United States

Requisition #:


Post Date:

Sep 28, 2021

**Careers that Change Lives**

As NPD team member you will help streamline and speed our time to market and build quality in at every step of the product cycle.You will be a member of the new product development team that supports the design and development of innovative, new products within the Surgical Innovations business. You can apply advanced technical concepts to complex problems from concept generation through early phase development.

_Impact patient outcomes.Come for a job, stay for a career._

**Medical Surgical**

The Medical Surgical Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.

SURGICAL INNOVATIONS strives to improve outcomes and quality of life for patients undergoing surgical procedures.

**A Day in the Life of EMC/Risk Management (RM) Engineer**

Be on the frontlines of medical device development as an integral member of the NPD team responsible for executing electromagnetic compatibility (EMC) systems and Risk Management processes for Medtronics Surgical Innovations medical devices. Work directly with RD teams to ensure all relevant systems requirements pertaining to EMC, integration points, risks are identified and evaluated, and appropriate and well-balanced solutions are implemented. Develop product EMC systems and Risk management deliverables to comply with standards / guidance documents.

**Responsibilities may include the following and other duties pertaining to EMC and Risk management may be assigned.**

+ Contribute to Medtronics understanding of current industry electromagnetic compatibility best practices and how they can be applied to SI Products.

+ As a RM specialist you will oversee the risk management process including risk identification, analysis, mitigation, monitoring and reduction.

+ Collaborate with cross-functional teams in developing and implementing risk management plan, and risk analyses based on Product requirements, Design Reviews, Change Orders and dFMEA, pFMEA and uFMEA (Use error).

+ Develop EMC test plan, in collaboration with RD, defining the test requirements as prescribed in National and International regulatory standards to assure compliance with applicable standards. In addition, lead risk analysis activities for each product lifecycle including conducting hazard analysis, FMEA meetings, and preparing all risk documentation per SOP

+ Serve as Risk Management SME on project team; make decisions and clearly communicate pertinent project/function information. Work with project team to determine clinical and cross-functional resources requirements.

+ Perform EMC and Wireless testing per the requirements detailed in National and international regulatory standards and test procedures in a laboratory environment

+ Prepare and review EMC test reports and provide constructive feedback to project team leads to mitigate and increase the overall EMC resilience quality of the final product

+ Assist in the resolution of non-compliance issues encountered during product testing, in collaboration with RD. Define laboratory requirements for pre-compliance and compliance testing

+ Perform risk assessment as part of post-market surveillance in support of complaint analysis, field corrective actions, design changes, product life cycle sustaining efforts, and others.

+ Provide ongoing EMC status updates and participate in project planning meetings as may be requested

+ Work, in collaboration with RD, with a recognized safety test laboratory to assure final submitted product conforms to EMC, RF and Safety compliance standards

+ Participate in product improvement activities by identifying, proposing, and leading process improvements within the function group. Enhance the product system risk documentation. Contribute to the development and updates of functional SOPs and WIs.

+ Serve as NPD RM specialist in internal/external audits and with regulatory authorities.

+ Keep abreast of emerging regulatory and industry trends regarding risk management.

**Must Have: Minimum Requirements**

+ Bachelors degree required

+ Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

**Nice to Have**

+ Good communication and presentation skills

+ Positive attitude, proactive mentality, responsive and strong work ethic is 100% required

+ Solid understanding of manufacturing, change control and risk management, and an awareness of regulatory trends

**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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Boulder, CO 80305

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