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<p class="MsoNormal">We are looking a passionate medical device engineer who is not afraid to tackle the broad range of challenges posed by bringing a device to market in a start-up environment. In return, we offer:</p>
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<li class="MsoNormal">A competitive compensation package including 'skin-in-the-game' (share option sheme)</li>
<li class="MsoNormal">Opportunities to oversee development of a Class 1 medical device from R&amp;D to launch</li>
<li class="MsoNormal">Training and support, either internally or externally, to help shape your future career</li>
<li class="MsoNormal">Flexible working and start-up energy</li>
</ul>
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<p class="MsoNormal"><strong>Senior Mechanical(£55,000-£75,000)</strong></p>
<p class="MsoNormal">For this position, we are looking for an engineer with a mechanical background who has at least 3 years of experience developing medical devices.</p>
<p class="MsoNormal">We expect the successful candidate to be able to take immediate ownership of the development of the mechanical aspects of our product and manage, with support from the CTO/any required training, a team which will grow swiftly. The team will deliver a medical device to market in 2-3 years. If the candidate does not have previous experience of leading a team and a scaling project, they must be able to demonstrate that they are ready to do so.</p>
<p class="MsoNormal">Broadly, the duties and responsibilities of this role include:</p>
<p class="MsoNormal">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Initially, your role will be to capture the design specification of the product and gain familiarity with the existing design. Going forward you will work with the CTO and electrical engineer to capture the evolving design requirements via surgeon labs and market research.</p>
<p class="MsoNormal">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; You will be responsible for continuing the design development of the product. This may include ideation, CAD work, drawing output, assembly and testing. You will lead junior/external team members to support this effort.</p>
<p class="MsoNormal">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; You will plan and document the product development, and liase as needed with notified bodies/test houses/consultants.</p>
<p class="MsoNormal">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; You will work with a regulatory specialist to capture the development in a manner compliant with our QMS.</p>
<p class="MsoNormal">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; As the project develops, you will support the transfer from concept development to design for manufacture, Verification and Validation testing and ultimately product launch.</p>
<p class="MsoNormal">The following are essential for this role:</p>
<ul type="disc">
<li class="MsoNormal">Product development experience including:</li>
<ul type="circle">
<li class="MsoNormal">Capturing design requirements</li>
<li class="MsoNormal">Ideation/rough prototyping</li>
<li class="MsoNormal">Experience with CAD solid modelling (eg. Solidworks), tolerancing and drawing/print generation</li>
</ul>
<li class="MsoNormal">A thorough understanding of the strengths/limitations of commonly used manufacturing techniques (eg. CNC machining, CNC turning, injection molding)</li>
<li class="MsoNormal">Understanding of the quality and regulatory requirements of med device design, including:</li>
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<li class="MsoNormal">US and EU/UK devices classes</li>
</ul>
</ul>
</ul>
<ul type="disc">
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<ul type="circle">
<li class="MsoNormal">Key rules and regulations governing such as MDD/MDR, UK CA, EU CE, US CFR21</li>
<li class="MsoNormal">Key electro-mechanical ISO standards (eg. BS EN ISO 60601-1:12)&nbsp;</li>
</ul>
</ul>
</ul>
<p class="MsoNormal">The following are desirable, but not required, for this role:</p>
<ul type="disc">
<li class="MsoNormal">Previous experience leading or as a senior team member on a medical device brought to market, including working within a compliant Quality Management System (QMS) or project management softwares.</li>
<li class="MsoNormal">Previous experience working with test houses to conduct testing to ISO standards</li>
<li class="MsoNormal">Previous experience interacting with notified/governing bodies (ie FDA)</li>
</ul>
<p class="MsoNormal">If you feel this is a role that you aspire to, but do not feel you currently have the experience for, please consider applying for our ‘mechanical engineer’ role – this role requires no previous experience. If this role is not posted, please contact us – we are flexible in creating roles for the right person.</p>
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Senior Mechanical Engineer

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