<h3>Job Description</h3>
Job Description
Title: &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Sr Risk Engineer/ Sr Reliability Engineer
Location: &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Minneapolis, MN 55432
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Job Description:
<ul>
<li>Looking for a Sr Risk Engineer to work within the Neuromodulation and Pelvic Health to drive the and support risk management sustaining activities.</li>
</ul>
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Must Have:
<ul>
<li>Demonstrated leadership skills with confidence in taking initiative and guiding teams effectively.</li>
<li>Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., Product Hazard Analysis, Design and Process FMEA, User Analysis).</li>
<li>Experience in the application of statistics.</li>
<li>Experience with Design Control Deliverables to include Product Performance Specifications, Design Verification, Design Validation, and Design Transfer, and Usability and Human Factor Engineering.</li>
<li>Experience with FDA 21 CFR 820, ISO 13485, European Union (EU) Medical Device Regulation (MDR), and State of the Art (SOTA).</li>
<li>Experience with implantable medical devices.</li>
<li>Highly proactive and able to anticipate needs, identify opportunities, and act independently to drive results.</li>
<li>Strong attention to detail with the ability to maintain accuracy and thoroughness in all aspects of work.</li>
</ul>