Senior Designs Assurance Quality Engineer

<table style="height: 1498.62px;" width="684"> <tbody> <tr style="height: 198.75px;"> <td style="width: 105.188px; height: 198.75px;" width="162"> <p>Job Description</p> </td> <td style="width: 551.229px; height: 198.75px;" width="522"> <p>Manage the Design Control and product design and change Risk Management processes for sterile catheter-, software-, electromechanical-based medical device product families.&nbsp; &nbsp;Provide Quality Engineering support for Product Development Projects throughout all phases of Design Controls (Concept to Launch) and Design Risk Management.</p> <p>This is a key contributor position working closely with R&amp;D, Operations, Commercial, Regulatory and Operations Quality to ensure compliance with AVI’s QMS and FDA QMSR requirements, with particular focus on Design Controls and Risk Management.</p> </td> </tr> <tr style="height: 590.656px;"> <td style="width: 105.188px; height: 590.656px;" width="162"> <p>Duties &amp;</p> <p>Responsibilities</p> </td> <td style="width: 551.229px; height: 590.656px;" width="522"> <p>· Responsible for overall Design Quality process to ensure that company design control projects comply with internal design control and risk management procedures in accordance with FDA, ISO and other applicable requirements</p> <p>· Lead cross functional teams to implement and periodically review hazard analyses, risk evaluation, assessment and other risk management processes</p> <p>· Provide guidance to project team members to ensure that design control requirements are being met in an effective manner in order to achieve quality by design</p> <p>· Support development, implementation and maintenance of Design Verification &amp; Validation methodologies and best practices to impact product quality and launch timeliness</p> <p>· Collaborate with Operations and Operations Quality to ensure effective and successful design transfer to manufacturing</p> <p>· Drive quality focused design and development of device software by defining the requirements, design, verification and validation plan and strategies while maintaining traceability and compliance to IEC 62304 and FDA guidance documents related to medical device software</p> <p>· Participate in product cybersecurity activities including product security planning, threat analysis, cybersecurity risk assessments, periodic monitoring and reporting</p> <p>· Act as a subject matter expert for Quality Engineering practices, such as statistical analysis, failure investigations, hazard identification and risk analysis, and quality data trending and analysis</p> <p>· Assist in Post-Market Surveill