Staff Manufacturing Engineer at Universal DX

About The Role

&lt;div class=&quot;content-intro&quot;&gt;&lt;p&gt;&lt;span class=&quot;TextRun SCXW90403494 BCX8&quot; lang=&quot;EN-US&quot; data-contrast=&quot;auto&quot;&gt;&lt;strong&gt;&lt;span class=&quot;NormalTextRun SCXW90403494 BCX8&quot;&gt;&lt;span class=&quot;TextRun SCXW180709537 BCX8&quot; lang=&quot;EN-US&quot; data-contrast=&quot;auto&quot;&gt;&lt;span class=&quot;NormalTextRun SCXW180709537 BCX8&quot;&gt;A&lt;/span&gt;&lt;span class=&quot;NormalTextRun SCXW180709537 BCX8&quot;&gt;bout &lt;/span&gt;&lt;span class=&quot;NormalTextRun SCXW180709537 BCX8&quot;&gt;our Company:&lt;/span&gt;&lt;/span&gt;&lt;span class=&quot;EOP SCXW180709537 BCX8&quot; data-ccp-props=&quot;{&amp;quot;335559685&amp;quot;:140,&amp;quot;335559738&amp;quot;:102}&quot;&gt;&amp;nbsp;&lt;/span&gt;&lt;/span&gt;&lt;/strong&gt;&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&lt;span class=&quot;TextRun SCXW90403494 BCX8&quot; lang=&quot;EN-US&quot; data-contrast=&quot;auto&quot;&gt;&lt;strong&gt;&lt;span class=&quot;NormalTextRun SCXW90403494 BCX8&quot;&gt;Universal D&lt;/span&gt;&lt;/strong&gt;&lt;span class=&quot;NormalTextRun SCXW90403494 BCX8&quot;&gt;&lt;strong&gt;X&lt;/strong&gt;, Inc&lt;/span&gt;&lt;span class=&quot;NormalTextRun SCXW90403494 BCX8&quot;&gt;.&lt;/span&gt;&lt;span class=&quot;NormalTextRun SCXW90403494 BCX8&quot;&gt; is an international&lt;/span&gt; &lt;span class=&quot;NormalTextRun SCXW90403494 BCX8&quot;&gt;Company&lt;/span&gt;&lt;span class=&quot;NormalTextRun SCXW90403494 BCX8&quot;&gt; with a &lt;/span&gt;&lt;span class=&quot;NormalTextRun SCXW90403494 BCX8&quot;&gt;highly experienced team focused on cracking cancer’s code. Through our multi-omics and &lt;/span&gt;&lt;span class=&quot;NormalTextRun SCXW90403494 BCX8&quot;&gt;bioinformatics &lt;/span&gt;&lt;span class=&quot;NormalTextRun SCXW90403494 BCX8&quot;&gt;models, we have figured out how to read the disease’s signals in &lt;/span&gt;&lt;span class=&quot;NormalTextRun SCXW90403494 BCX8&quot;&gt;blood &lt;/span&gt;&lt;span class=&quot;NormalTextRun SCXW90403494 BCX8&quot;&gt;with high accuracy &lt;/span&gt;&lt;span class=&quot;NormalTextRun SCXW90403494 BCX8&quot;&gt;to detect &lt;/span&gt;&lt;span class=&quot;NormalTextRun SCXW90403494 BCX8&quot;&gt;cancer&lt;/span&gt;&lt;span class=&quot;NormalTextRun SCXW90403494 BCX8&quot;&gt; in its earliest stages. Starting with &lt;/span&gt;&lt;span class=&quot;NormalTextRun SCXW90403494 BCX8&quot;&gt;a &lt;/span&gt;&lt;span class=&quot;NormalTextRun SCXW90403494 BCX8&quot;&gt;colorectal cancer&lt;/span&gt;&lt;span class=&quot;NormalTextRun SCXW90403494 BCX8&quot;&gt; screening&lt;/span&gt;&lt;span class=&quot;NormalTextRun SCXW90403494 BCX8&quot;&gt; liquid biopsy test&lt;/span&gt;&lt;span class=&quot;NormalTextRun SCXW90403494 BCX8&quot;&gt;, we are building a multi-cancer platform that can &lt;/span&gt;&lt;span class=&quot;NormalTextRun SCXW90403494 BCX8&quot;&gt;identify&lt;/span&gt;&lt;span class=&quot;NormalTextRun SCXW90403494 BCX8&quot;&gt; the unique DNA regions associated with &lt;/span&gt;&lt;span class=&quot;NormalTextRun SCXW90403494 BCX8&quot;&gt;different types&lt;/span&gt;&lt;span class=&quot;NormalTextRun SCXW90403494 BCX8&quot;&gt; of cancers.&lt;/span&gt;&lt;/span&gt;&lt;span class=&quot;EOP SCXW90403494 BCX8&quot; data-ccp-props=&quot;{&amp;quot;335551550&amp;quot;:6,&amp;quot;335551620&amp;quot;:6,&amp;quot;335559685&amp;quot;:140,&amp;quot;335559737&amp;quot;:191}&quot;&gt;&amp;nbsp;&lt;/span&gt;&lt;/p&gt;&lt;/div&gt;&lt;p&gt;&lt;strong&gt;&lt;span data-contrast=&quot;none&quot;&gt;&lt;span data-ccp-parastyle=&quot;JD Heading&quot; data-ccp-parastyle-defn=&quot;{&amp;quot;ObjectId&amp;quot;:&amp;quot;3c546d88-e673-5436-b9a3-2e981cd096ba|1&amp;quot;,&amp;quot;ClassId&amp;quot;:1073872969,&amp;quot;Properties&amp;quot;:[469775450,&amp;quot;JD Heading&amp;quot;,201340122,&amp;quot;2&amp;quot;,134233614,&amp;quot;true&amp;quot;,469778129,&amp;quot;JDHeading&amp;quot;,335572020,&amp;quot;1&amp;quot;,134224900,&amp;quot;true&amp;quot;,469777841,&amp;quot;Arial&amp;quot;,469777843,&amp;quot;Arial&amp;quot;,469777844,&amp;quot;Arial&amp;quot;,469769226,&amp;quot;Arial&amp;quot;,335551500,&amp;quot;2302755&amp;quot;,268442635,&amp;quot;23&amp;quot;,335559740,&amp;quot;276&amp;quot;,201341983,&amp;quot;0&amp;quot;,335559739,&amp;quot;200&amp;quot;,201342446,&amp;quot;1&amp;quot;,201342447,&amp;quot;5&amp;quot;,201342448,&amp;quot;1&amp;quot;,201342449,&amp;quot;1&amp;quot;,469777842,&amp;quot;&amp;quot;,201341986,&amp;quot;1&amp;quot;]}&quot;&gt;The Opportunity:&lt;/span&gt;&lt;/span&gt;&lt;/strong&gt;&lt;span data-ccp-props=&quot;{&amp;quot;201341983&amp;quot;:0,&amp;quot;335559738&amp;quot;:140,&amp;quot;335559739&amp;quot;:80,&amp;quot;335559740&amp;quot;:276}&quot;&gt;&amp;nbsp;&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&lt;span data-contrast=&quot;auto&quot;&gt;We are seeking a Staff Manufacturing Engineer to provide cross-functional leadership for Manufacturing readiness, program execution, systems, risk management, and continuous improvement across our diagnostic manufacturing operations. This role will connect Manufacturing with internal customers, R&amp;amp;D, Quality, Supply Chain, external partners, and digital-system stakeholders to ensure new and ongoing manufacturing campaigns are execution-ready, visible, scalable, and well controlled. The ideal candidate combines strong manufacturing engineering judgment with program leadership, systems thinking, and experience operating in regulated diagnostic or life-science environments.&lt;/span&gt;&lt;span data-ccp-props=&quot;{&amp;quot;201341983&amp;quot;:0,&amp;quot;335551550&amp;quot;:6,&amp;quot;335551620&amp;quot;:6,&amp;quot;335559739&amp;quot;:100,&amp;quot;335559740&amp;quot;:247}&quot;&gt;&amp;nbsp;&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&lt;span data-contrast=&quot;auto&quot;&gt;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”.&lt;/span&gt;&lt;span data-ccp-props=&quot;{&amp;quot;201341983&amp;quot;:0,&amp;quot;335551550&amp;quot;:6,&amp;quot;335551620&amp;quot;:6,&amp;quot;335559739&amp;quot;:100,&amp;quot;335559740&amp;quot;:247}&quot;&gt;&amp;nbsp;&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&amp;nbsp;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;span data-contrast=&quot;none&quot;&gt;&lt;span data-ccp-parastyle=&quot;JD Heading&quot; data-ccp-parastyle-defn=&quot;{&amp;quot;ObjectId&amp;quot;:&amp;quot;3c546d88-e673-5436-b9a3-2e981cd096ba|1&amp;quot;,&amp;quot;ClassId&amp;quot;:1073872969,&amp;quot;Properties&amp;quot;:[469775450,&amp;quot;JD Heading&amp;quot;,201340122,&amp;quot;2&amp;quot;,134233614,&amp;quot;true&amp;quot;,469778129,&amp;quot;JDHeading&amp;quot;,335572020,&amp;quot;1&amp;quot;,134224900,&amp;quot;true&amp;quot;,469777841,&amp;quot;Arial&amp;quot;,469777843,&amp;quot;Arial&amp;quot;,469777844,&amp;quot;Arial&amp;quot;,469769226,&amp;quot;Arial&amp;quot;,335551500,&amp;quot;2302755&amp;quot;,268442635,&amp;quot;23&amp;quot;,335559740,&amp;quot;276&amp;quot;,201341983,&amp;quot;0&amp;quot;,335559739,&amp;quot;200&amp;quot;,201342446,&amp;quot;1&amp;quot;,201342447,&amp;quot;5&amp;quot;,201342448,&amp;quot;1&amp;quot;,201342449,&amp;quot;1&amp;quot;,469777842,&amp;quot;&amp;quot;,201341986,&amp;quot;1&amp;quot;]}&quot;&gt;How&amp;nbsp;&lt;/span&gt;&lt;span data-ccp-parastyle=&quot;JD Heading&quot;&gt;you’ll&lt;/span&gt;&lt;span data-ccp-parastyle=&quot;JD Heading&quot;&gt; contribute:&lt;/span&gt;&lt;/span&gt;&lt;/strong&gt;&lt;span data-ccp-props=&quot;{&amp;quot;201341983&amp;quot;:0,&amp;quot;335559738&amp;quot;:140,&amp;quot;335559739&amp;quot;:80,&amp;quot;335559740&amp;quot;:276}&quot;&gt;&amp;nbsp;&lt;/span&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;&lt;strong&gt; &lt;/strong&gt;&lt;span data-contrast=&quot;auto&quot;&gt;Represent Manufacturing in technical and operational discussions with internal customers and external partners regarding manufacturing capability, readiness, timelines, process implementation, and operational requirements.&lt;/span&gt;&lt;/li&gt;
&lt;li&gt;&lt;strong&gt; &lt;/strong&gt;&lt;span data-contrast=&quot;auto&quot;&gt;Define Manufacturing business requirements for Smartsheet, Jira, LIMS/MES, dashboards, and other digital tools. Develop scalable workflows that improve traceability, operational visibility, and execution.&lt;/span&gt;&lt;/li&gt;
&lt;li&gt;&lt;strong&gt; &lt;/strong&gt;&lt;span data-contrast=&quot;auto&quot;&gt;Lead post-sprint reviews, identify systemic issues and improvement opportunities, and convert lessons learned into sustainable improvements for future manufacturing campaigns.&lt;/span&gt;&lt;/li&gt;
&lt;li&gt;&lt;strong&gt; &lt;/strong&gt;&lt;span data-contrast=&quot;auto&quot;&gt;Maintain an integrated view of manufacturing milestones, dependencies, risks, and critical-path activities. Lead readiness reviews and escalate risks that could affect quality, schedule, or delivery.&lt;/span&gt;&lt;/li&gt;
&lt;li&gt;&lt;strong&gt; &lt;/strong&gt;&lt;span data-contrast=&quot;auto&quot;&gt;Coordinate Manufacturing readiness for new products and processes transitioning from R&amp;amp;D, other sites, or external partners. Lead gap assessments, implementation planning, and execution readiness across equipment, materials, training, documentation, and operational requirements.&lt;/span&gt;&lt;/li&gt;
&lt;li&gt;&lt;strong&gt; &lt;/strong&gt;&lt;span data-contrast=&quot;auto&quot;&gt;Maintain Manufacturing audit readiness through periodic assessments, evidence reviews, gap closure, and coordination with Quality. Ensure manufacturing records, training evidence, equipment status, material traceability, and supporting information are readily retrievable.&lt;/span&gt;&lt;/li&gt;
&lt;li&gt;&lt;strong&gt; &lt;/strong&gt;&lt;span data-contrast=&quot;auto&quot;&gt;Develop and maintain meaningful Manufacturing metrics, including sprint readiness, schedule adherence, overdue actions, supplier readiness, documentation readiness, deviations, and recurring operational risks.&lt;/span&gt;&lt;/li&gt;
&lt;li&gt;&lt;strong&gt; &lt;/strong&gt;&lt;span data-contrast=&quot;auto&quot;&gt;Ensure required manufacturing procedures, batch records, forms, specifications, and supporting documents are identified and ready before execution. Coordinate with document owners, Quality, and Document Control without serving as the primary document-control owner.&lt;/span&gt;&lt;/li&gt;
&lt;li&gt;&lt;strong&gt; &lt;/strong&gt;&lt;span data-contrast=&quot;auto&quot;&gt;Facilitate structured readiness and decision-making forums, drive follow-through on action items, and provide clear status, risk, and escalation summaries to Manufacturing leadership.&lt;/span&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&amp;nbsp;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;span data-contrast=&quot;none&quot;&gt;&lt;span data-ccp-parastyle=&quot;JD Heading&quot;&gt;What&amp;nbsp;&lt;/span&gt;&lt;span data-ccp-parastyle=&quot;JD Heading&quot;&gt;you’ll&lt;/span&gt;&lt;span data-ccp-parastyle=&quot;JD Heading&quot;&gt; bring:&lt;/span&gt;&lt;/span&gt;&lt;/strong&gt;&lt;span data-ccp-props=&quot;{&amp;quot;201341983&amp;quot;:0,&amp;quot;335559738&amp;quot;:140,&amp;quot;335559739&amp;quot;:80,&amp;quot;335559740&amp;quot;:276}&quot;&gt;&amp;nbsp;&lt;/span&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;&lt;strong&gt; &lt;/strong&gt;&lt;span data-contrast=&quot;auto&quot;&gt;PhD in Biotechnology, Engineering, Life Sciences or a related technical discipline; advanced degree preferred.&lt;/span&gt;&lt;/li&gt;
&lt;li&gt;&lt;strong&gt; &lt;/strong&gt;&lt;span data-contrast=&quot;auto&quot;&gt;Typically 7+ years of industry experience in study design, documentation, manufacturing, diagnostic or&amp;nbsp; biopharma, reagent manufacturing environments.&lt;/span&gt;&lt;/li&gt;
&lt;li&gt;&lt;strong&gt; &lt;/strong&gt;&lt;span data-contrast=&quot;auto&quot;&gt;Demonstrated experience leading cross-functional manufacturing readiness, technology transfer, new product introduction, or complex operational programs.&lt;/span&gt;&lt;/li&gt;
&lt;li&gt;&lt;strong&gt; &lt;/strong&gt;&lt;span data-contrast=&quot;auto&quot;&gt;Strong working knowledge of GMP/GDP principles, ISO 13485, change control, deviations/CAPA, training, equipment/material readiness, and manufacturing documentation.&lt;/span&gt;&lt;/li&gt;
&lt;li&gt;&lt;strong&gt; &lt;/strong&gt;&lt;span data-contrast=&quot;auto&quot;&gt;Experience translating operational needs into scalable digital workflows, dashboards, trackers, or LIMS/MES business requirements.&lt;/span&gt;&lt;/li&gt;
&lt;li&gt;&lt;strong&gt; &lt;/strong&gt;&lt;span data-contrast=&quot;auto&quot;&gt;Strong risk-management, problem-solving, facilitation, and executive communication skills with the ability to manage multiple interdependent priorities.&lt;/span&gt;&lt;/li&gt;
&lt;li&gt;&lt;strong&gt; &lt;/strong&gt;&lt;span data-contrast=&quot;auto&quot;&gt;Experience supporting audits or inspections and maintaining evidence-based manufacturing readiness.&lt;/span&gt;&lt;/li&gt;
&lt;li&gt;&lt;strong&gt; &lt;/strong&gt;&lt;span data-contrast=&quot;auto&quot;&gt;Ability to work effectively in a remote environment while maintaining strong engagement with Dallas-based Manufacturing operations and cross-functional partners.&lt;/span&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&amp;nbsp;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;&lt;span data-contrast=&quot;none&quot;&gt;&lt;span data-ccp-parastyle=&quot;JD Heading&quot;&gt;What&amp;nbsp;&lt;/span&gt;&lt;span data-ccp-parastyle=&quot;JD Heading&quot;&gt;we’ll&lt;/span&gt;&lt;span data-ccp-parastyle=&quot;JD Heading&quot;&gt; offer:&lt;/span&gt;&lt;/span&gt;&lt;/strong&gt;&lt;span data-ccp-props=&quot;{&amp;quot;201341983&amp;quot;:0,&amp;quot;335559738&amp;quot;:140,&amp;quot;335559739&amp;quot;:80,&amp;quot;335559740&amp;quot;:276}&quot;&gt;&amp;nbsp;&lt;/span&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;&lt;strong&gt; &lt;/strong&gt;&lt;span data-contrast=&quot;auto&quot;&gt;22 days of PTO with the possibility to carry over 10 days to the following year.&lt;/span&gt;&lt;/li&gt;
&lt;li&gt;&lt;strong&gt; &lt;/strong&gt;&lt;span data-contrast=&quot;auto&quot;&gt;Company Holidays, plus your Birthday off!&lt;/span&gt;&lt;/li&gt;
&lt;li&gt;&lt;strong&gt; &lt;/strong&gt;&lt;span data-contrast=&quot;auto&quot;&gt;Company-sponsored benefit plans, including medical, dental, and vision insurance plus life, STD, and LTD coverage, and 401(k).&lt;/span&gt;&lt;/li&gt;
&lt;li&gt;&lt;strong&gt; &lt;/strong&gt;&lt;span data-contrast=&quot;auto&quot;&gt;Flexible work schedule.&lt;/span&gt;&lt;/li&gt;
&lt;li&gt;&lt;strong&gt; &lt;/strong&gt;&lt;span data-contrast=&quot;auto&quot;&gt;And more to come!&lt;/span&gt;&lt;/li&gt;
&lt;/ul&gt;&lt;div class=&quot;content-conclusion&quot;&gt;&lt;p&gt;&lt;span data-ccp-props=&quot;{&amp;quot;335551550&amp;quot;:6,&amp;quot;335551620&amp;quot;:6,&amp;quot;335559685&amp;quot;:140,&amp;quot;335559737&amp;quot;:191}&quot;&gt;&amp;nbsp;&lt;/span&gt;&lt;strong&gt;&lt;span data-contrast=&quot;auto&quot;&gt;Why Now?&lt;/span&gt;&lt;/strong&gt;&lt;span data-ccp-props=&quot;{&amp;quot;335559731&amp;quot;:140,&amp;quot;335559737&amp;quot;:247}&quot;&gt;&amp;nbsp;&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&lt;span data-contrast=&quot;auto&quot;&gt;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.&amp;nbsp;&lt;/span&gt;&lt;span data-ccp-props=&quot;{&amp;quot;335551550&amp;quot;:6,&amp;quot;335551620&amp;quot;:6,&amp;quot;335559685&amp;quot;:140,&amp;quot;335559737&amp;quot;:247}&quot;&gt;&amp;nbsp;&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&lt;span data-contrast=&quot;auto&quot;&gt;We are looking for passionate changemakers to be a part of our journey in this expansive time for us.&lt;/span&gt;&lt;span data-ccp-props=&quot;{&amp;quot;335551550&amp;quot;:6,&amp;quot;335551620&amp;quot;:6,&amp;quot;335559685&amp;quot;:140,&amp;quot;335559737&amp;quot;:247}&quot;&gt;&amp;nbsp;&lt;/span&gt;&lt;/p&gt;&lt;/div&gt;