Senior Design Assurance Engineer

<p>At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.</p><p></p><h1><b>A Day in the Life</b></h1><p><b><span>Medtronic</span></b><span> </span></p><p><span><span>At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.</span></span><span> </span></p><p><span> </span></p><p><b><span>Our Purpose </span></b><span> </span></p><p><span><span>Within our Structural Heart Design Assurance Group in Medtronic, plc, we focus on providing Quality support across all aspects of PDP from </span><span>pre market</span><span> product development to post market product surveillance. We </span><span>participate</span><span> in the design process to ensure the performance and safety of the Structural Heart devices we develop, </span><span>is</span><span> assured and </span><span>maintained</span><span> throughout the product lifecycle.</span></span><span> </span></p><p><span> </span></p><p><i><span>Come for a job, stay for a career!</span></i><span> </span></p><p><span> </span></p><p><b><span>A Day </span><span>i</span><span>n </span><span>The Life</span><span> Of:</span></b><span> </span></p><ul><li><p><span><span>You will serve as extended team member on a PDP Project </span><span>representing</span><span> the Design Assurance function and will report dotted line to the quality lead on the project.</span></span><span> </span></p></li></ul><ul><li><p><span><span>You will lead strategies for risk management, test method validations, design </span><span>verification</span><span> and shelf-life protocols / reports.</span></span><span> </span></p></li></ul><ul><li><p><span><span>You will </span><span>be responsible for</span><span> keeping abreast of industry best practice with respect to product design.</span></span><span> </span></p></li></ul><ul><li><p><span><span>You will </span><span>maintain</span><span> expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, </span><span>transfer</span><span> and commercialisation activities. </span></span><span> </span></p></li></ul><ul><li><p><span><span>You will </span><span>be required</span><span> to liaise with departments, both internally and externally to build strong collaborative partnerships.</span></span><span> </span></p></li></ul><ul><li><p><span><span>You will </span><span>be required</span><span> to provide Quality input into new product development, process </span><span>improvements</span><span> and change control.</span></span><span> </span></p></li></ul><ul><li><p><span><span>As required, you will support cross functional teams to design protocols to ensure that new products/ product changes are adequately evaluated/tested with respect to standard requirements.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Provides </span><span>expertise</span><span> and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.</span></span><span> </span></p></li></ul><p><span> </span></p><p><b><span>Key Skills &amp; Experience </span></b><span> </span></p><ul><li><p><span><span>Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Requires a minimum Level 8 degree in Engineering or other relevant discipline with minimum 4 years’ relevant experience.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Experience in a highly regulated industry, preferably medical devices.</span></span><span> </span></p></li></ul><ul><li><p><span><span>You are a dynamic team player and leader and can work effectively and proactively on cross-functional teams</span><span>.</span></span><span> </span></p></li></ul><ul><li><p><span><span>You are experienced to a competent level within Medical Device product design.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Initiates and Leads Change, Collaborates and Creates Alignment, Drives Accountability and Thinks Critically and Makes Sound Decisions are </span><span>a must</span><span>.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Excellent communication and ability to influence is critical to the role.</span></span><span> </span></p></li></ul><ul><li><p><span><span>Flexibility to travel &lt;10% of time desirable.</span></span><span> </span></p></li></ul><p><span> </span></p><p><b><span>Medtronic offer a competitive </span><span>s</span><span>alary and flexible Benefits Package</span></b><span> </span></p><p></p><p>#IJ</p><p></p><p></p><p><b>Physical Job Requirements</b><br/><br/>The above statements are intended to describe the general