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Senior Systems Engineer

Universal DX · United States

Diagnostics / LaboratoryImported listingfull-time1 day ago

About The Role

<div class="content-intro"><p><span class="TextRun SCXW90403494 BCX8" lang="EN-US" data-contrast="auto"><strong><span class="NormalTextRun SCXW90403494 BCX8"><span class="TextRun SCXW180709537 BCX8" lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW180709537 BCX8">A</span><span class="NormalTextRun SCXW180709537 BCX8">bout </span><span class="NormalTextRun SCXW180709537 BCX8">our Company:</span></span><span class="EOP SCXW180709537 BCX8" data-ccp-props="{"335559685":140,"335559738":102}"> </span></span></strong></span></p>
<p><span class="TextRun SCXW90403494 BCX8" lang="EN-US" data-contrast="auto"><strong><span class="NormalTextRun SCXW90403494 BCX8">Universal D</span></strong><span class="NormalTextRun SCXW90403494 BCX8"><strong>X</strong>, Inc</span><span class="NormalTextRun SCXW90403494 BCX8">.</span><span class="NormalTextRun SCXW90403494 BCX8"> is an international</span> <span class="NormalTextRun SCXW90403494 BCX8">Company</span><span class="NormalTextRun SCXW90403494 BCX8"> with a </span><span class="NormalTextRun SCXW90403494 BCX8">highly experienced team focused on cracking cancer’s code. Through our multi-omics and </span><span class="NormalTextRun SCXW90403494 BCX8">bioinformatics </span><span class="NormalTextRun SCXW90403494 BCX8">models, we have figured out how to read the disease’s signals in </span><span class="NormalTextRun SCXW90403494 BCX8">blood </span><span class="NormalTextRun SCXW90403494 BCX8">with high accuracy </span><span class="NormalTextRun SCXW90403494 BCX8">to detect </span><span class="NormalTextRun SCXW90403494 BCX8">cancer</span><span class="NormalTextRun SCXW90403494 BCX8"> in its earliest stages. Starting with </span><span class="NormalTextRun SCXW90403494 BCX8">a </span><span class="NormalTextRun SCXW90403494 BCX8">colorectal cancer</span><span class="NormalTextRun SCXW90403494 BCX8"> screening</span><span class="NormalTextRun SCXW90403494 BCX8"> liquid biopsy test</span><span class="NormalTextRun SCXW90403494 BCX8">, we are building a multi-cancer platform that can </span><span class="NormalTextRun SCXW90403494 BCX8">identify</span><span class="NormalTextRun SCXW90403494 BCX8"> the unique DNA regions associated with </span><span class="NormalTextRun SCXW90403494 BCX8">different types</span><span class="NormalTextRun SCXW90403494 BCX8"> of cancers.</span></span><span class="EOP SCXW90403494 BCX8" data-ccp-props="{"335551550":6,"335551620":6,"335559685":140,"335559737":191}"> </span></p></div><p><strong><span data-contrast="none">The Opportunity:</span></strong><span data-ccp-props="{"335551550":6,"335551620":6,"335559685":140,"335559737":191}"> </span></p>
<p><span data-contrast="none">Universal DX, Inc is seeking an experienced Senior Systems Engineer to join our growing team. In this role, you will work directly with the Director of Software Lifecycle and Compliance and play a critical role in supporting the development of next-generation bioinformatics, computational biology, and laboratory automation software in compliance with IEC 62304, ISO 14971, FDA design controls, and Computer System Validation (CSV)/Computer Software Assurance (CSA) expectations for Class III (PMA) medical devices and IVD systems.</span><span data-ccp-props="{"335551550":6,"335551620":6,"335559685":140,"335559737":191}"> </span></p>
<p><span data-contrast="none">You will contribute as a senior technical individual contributor responsible for systems engineering activities across assigned systems and workstreams, including requirements development, interface definition, risk management, verification planning, test development and execution, and lifecycle traceability.</span><span data-ccp-props="{"335551550":6,"335551620":6,"335559685":140,"335559737":191}"> </span></p>
<p><span data-contrast="none">You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers. As part of the team, you will be in a Company that aims more than to become one of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of “making cancer a curable disease by detecting it earlier”.</span><span data-ccp-props="{"335551550":6,"335551620":6,"335559685":140,"335559737":191}"> </span></p>
<p><span data-ccp-props="{"335551550":6,"335551620":6,"335559685":140,"335559737":191}"> </span></p>
<p><strong><span data-contrast="none">How you’ll contribute:</span></strong><span data-ccp-props="{"335559685":140,"335559738":1}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="heading 2">Systems and </span><span data-ccp-parastyle="heading 2">Requirements Engineering</span></span><span data-ccp-props="{"134245418":true,"134245529":true,"335559731":140,"335559738":40}"> </span></p>
<p><span data-contrast="none">Independently develop, refine, review, and maintain software and system requirements for regulated IVD software, bioinformatics pipelines, computational biology platforms, laboratory automation systems, and supporting validated software tools in alignment with IEC 62304 and FDA expectations for Class III medical devices </span><span data-ccp-props="{"134233117":true,"134233118":true,"134245417":true}"> </span></p>
<ul>
<li><span data-contrast="none">Ensure end-to-end traceability </span></li>
<li><span data-contrast="none"><span data-ccp-parastyle="heading 2">Risk Management </span></span><span data-ccp-props="{"134245418":true,"134245529":true,"335559731":360,"335559738":40}"> </span></li>
<li><span data-contrast="none"><span data-ccp-parastyle="heading 2">Computer System Validation (CSV) & Compliance Support</span></span><span data-ccp-props="{"134245418":true,"134245529":true,"335559731":360,"335559738":40}"> </span></li>
<li><span data-contrast="none"><span data-ccp-parastyle="heading 2">Cross-Functional Collaboration</span></span> <span data-ccp-props="{"134233117":true,"134233118":true,"134245417":true}"> </span></li>
<li><span data-contrast="none"><span data-ccp-parastyle="heading 2">Verification & Compliance Support</span></span><span data-ccp-props="{"134245418":true,"134245529":true,"335559731":360,"335559738":40}"> </span><span data-ccp-props="{"134233117":true,"134233118":true,"134245417":true}"> </span></li>
<li><span data-contrast="none"><span data-ccp-parastyle="heading 2">Tools & Process Support</span></span> <span data-ccp-props="{"134233117":true,"134233118":true,"134245417":true}"> </span></li>
</ul>
<p> </p>
<p><strong><span data-contrast="none">What you’ll bring:</span></strong><span data-ccp-props="{"201341983":1,"335559685":140,"335559738":1,"335559740":234}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="heading 2">Required Qualifications</span></span><span data-ccp-props="{"134245418":true,"134245529":true,"335559731":140,"335559738":40}"> </span></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="48" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none">Bachelor’s, Master’s, or Ph.D. degree in Engineering, Computer Science, Bioinformatics, Computational Biology, Biology, or a related technical discipline </span><span data-ccp-props="{"134233117":true,"134233118":true,"134245417":true}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="48" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="none">3+ years of experience creating and managing software requirements for Class III (PMA) medical device software or regulated IVD systems </span><span data-ccp-props="{"134233117":true,"134233118":true,"134245417":true}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="48" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="none">5+ years of experience in software requirements analysis, systems engineering, business analysis, software compliance, or related healthcare software development activities </span><span data-ccp-props="{"134233117":true,"134233118":true,"134245417":true}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="48" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="none">Experience with IEC 62304 software lifecycle processes and FDA design controls for medical device software </span><span data-ccp-props="{"134233117":true,"134233118":true,"134245417":true}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="48" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="none">Experience creating and managing risk management activities aligned with ISO 14971 </span><span data-ccp-props="{"134233117":true,"134233118":true,"134245417":true}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="48" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="none">Experience supporting Computer System Validation (CSV) and/or Computer Software Assurance (CSA) activities in regulated healthcare, laboratory, or medical device environments </span><span data-ccp-props="{"134233117":true,"134233118":true,"134245417":true}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="48" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="none">Prior experience supporting bioinformatics pipelines, computational biology software, laboratory automation workflows, or validated laboratory software systems in a regulated environment </span><span data-ccp-props="{"134233117":true,"134233118":true,"134245417":true}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="48" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="none">Experience collaborating cross-functionally with software engineers, computational biologists, automation engineers, QA, V&V, and R&D stakeholders </span><span data-ccp-props="{"134233117":true,"134233118":true,"134245417":true}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="48" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="9" data-aria-level="1"><span data-contrast="none">Strong technical writing, analytical, and traceability management skills </span><span data-ccp-props="{"134233117":true,"134233118":true,"134245417":true}"> </span></li>
</ul>
<p><span data-contrast="none"><span data-ccp-parastyle="heading 2">Preferred Qualifications</span></span><span data-ccp-props="{"134245418":true,"134245529":true,"335559731":360,"335559738":40}"> </span></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="49" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none">Prior experience supporting PMA submissions or FDA regulatory inspections </span><span data-ccp-props="{"134233117":true,"134233118":true,"134245417":true}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="49" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="none">Experience with In Vitro Diagnostic (IVD) medical devices and CLIA laboratory environments </span><span data-ccp-props="{"134233117":true,"134233118":true,"134245417":true}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="49" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="none">Familiarity with 21 CFR Part 11 and data integrity expectations for validated software systems </span><span data-ccp-props="{"134233117":true,"134233118":true,"134245417":true}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="49" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="none">Experience with requirements management and traceability tools such as <span data-ccp-charstyle="whitespace-normal" data-ccp-charstyle-defn="{"ObjectId":"c66ef6be-b785-5f4e-bbb9-1327dfc155ae|1","ClassId":1073872969,"Properties":[201342446,"1",201342447,"5",201342448,"1",201342449,"1",469777841,"Calibri",469777842,"",469777843,"Calibri",469777844,"Calibri",201341986,"1",469769226,"Calibri",268442635,"22",469775450,"whitespace-normal",201340122,"1",134233614,"true",469778129,"whitespace-normal",335572020,"1",469778324,"Default Paragraph Font"]}">Polarion</span>, <span data-ccp-charstyle="whitespace-normal">Jama Connect</span>, or <span data-ccp-charstyle="whitespace-normal">IBM DOORS</span> </span><span data-ccp-props="{"134233117":true,"134233118":true,"134245417":true}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="49" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="none">Familiarity with laboratory automation workflows, sequencing pipelines, or NGS-based diagnostic systems </span><span data-ccp-props="{"134233117":true,"134233118":true,"134245417":true}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="49" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="none">Understanding of software verification and validation methodologies in regulated environments </span><span data-ccp-props="{"134233117":true,"134233118":true,"134245417":true}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="49" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="none">Ability to rapidly learn and support new technical domains and software functionality </span><span data-ccp-props="{"134233117":true,"134233118":true,"134245417":true}"> </span></li>
</ul>
<p> </p>
<p><strong><span data-contrast="none">What we´ll offer:</span></strong><span data-ccp-props="{"335559685":140}"> </span></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{"335552541":1,"335559685":936,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none">22 days of PTO with the possibility to carry over 10 days to the following year.</span><span data-contrast="none"> </span><span data-ccp-props="{}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{"335552541":1,"335559685":936,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="none">Company Holidays, plus your Birthday off! </span><span data-contrast="none"> </span><span data-ccp-props="{}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{"335552541":1,"335559685":936,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="none">Company-sponsored benefit plans, including medical, dental, and vision insurance plus life, STD, and LTD coverage, and 401(k).</span><span data-contrast="none"> </span><span data-ccp-props="{}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{"335552541":1,"335559685":936,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="none">Flexible work schedule </span><span data-contrast="none"> </span><span data-ccp-props="{}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{"335552541":1,"335559685":936,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="none">And more to come!</span><span data-contrast="none"> </span><span data-ccp-props="{}"> </span></li>
</ul><div class="content-conclusion"><p><span data-ccp-props="{"335551550":6,"335551620":6,"335559685":140,"335559737":191}"> </span><strong><span data-contrast="auto">Why Now?</span></strong><span data-ccp-props="{"335559731":140,"335559737":247}"> </span></p>
<p><span data-contrast="auto">This is an exciting time to be at Universal DX. We are growing rapidly and starting our US operations by building up our team, starting our lab and business operations, and establishing strategic partnerships. </span><span data-ccp-props="{"335551550":6,"335551620":6,"335559685":140,"335559737":247}"> </span></p>
<p><span data-contrast="auto">We are looking for passionate changemakers to be a part of our journey in this expansive time for us.</span><span data-ccp-props="{"335551550":6,"335551620":6,"335559685":140,"335559737":247}"> </span></p></div>

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