Staff Manufacturing Engineer
Role Overview
The Staff Manufacturing Engineer provides cross-functional leadership for manufacturing readiness, program execution, systems, risk management, and continuous improvement.
The role connects Manufacturing with internal customers, R&D, Quality, Supply Chain, external partners, and digital-system stakeholders.
The goal is to make manufacturing campaigns execution-ready, visible, scalable, and controlled in regulated diagnostic or life-science environments.
Key Skills for This Role
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About the company
Universal DX develops diagnostic tests for early cancer detection and is building its U.S. operations, laboratory, and business partnerships.
The opportunity
The Staff Manufacturing Engineer provides cross-functional leadership for manufacturing readiness, program execution, systems, risk management, and continuous improvement.
The role connects Manufacturing with internal customers, R&D, Quality, Supply Chain, external partners, and digital-system stakeholders.
The goal is to make manufacturing campaigns execution-ready, visible, scalable, and controlled in regulated diagnostic or life-science environments.
Responsibilities
- Represent Manufacturing in discussions with internal customers and external partners about capability, readiness, timelines, and operational requirements.
- Define digital-tool requirements for Smartsheet, Jira, LIMS/MES, and dashboards; develop scalable workflows.
- Lead post-sprint reviews and turn lessons learned into sustainable improvements.
- Track milestones, dependencies, risks, and critical-path activities; lead readiness reviews and escalate risks.
- Coordinate product and process transitions, gap assessments, and readiness across equipment, materials, training, documentation, and operations.
- Maintain audit readiness, coordinate evidence reviews and gap closure, and develop manufacturing metrics.
- Ensure required procedures, batch records, forms, specifications, and supporting documents are ready before execution.
- Facilitate readiness forums, follow up on actions, and provide status and risk summaries to Manufacturing leadership.
Required qualifications
- PhD in Biotechnology, Engineering, Life Sciences, or a related technical discipline; advanced degree preferred.
- Typically 7 or more years of industry experience in study design, documentation, manufacturing, diagnostics or biopharma, or reagent manufacturing.
- Experience leading cross-functional manufacturing readiness, technology transfer, new product introduction, or complex operational programs.
- Strong knowledge of GMP/GDP, ISO 13485, change control, deviations/CAPA, training, equipment and material readiness, and manufacturing documentation.
- Experience translating operational needs into digital workflows, dashboards, trackers, or LIMS/MES business requirements.
- Strong risk management, problem-solving, facilitation, and executive communication skills; able to manage interdependent priorities.
- Experience supporting audits or inspections and maintaining evidence-based readiness.
- Able to work remotely while engaging with Dallas-based Manufacturing operations and cross-functional partners.
Benefits
- 22 days of paid time off, with up to 10 days eligible for carryover; company holidays and birthday off.
- Company-sponsored medical, dental, vision, life, short-term and long-term disability coverage, and 401(k).
- Flexible work schedule.
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