Staff Manufacturing Engineer

Universal Diagnostics; United States; Remote; USD 120,000 - 170,000; Full time

Benefits offered by this job

22 days PTO

Company Holidays + Birthday off

Medical, dental, vision; life, STD, LT

401(k)

Flexible schedule

Job summary

Universal D X, Inc. is seeking a Staff Manufacturing Engineer to lead manufacturing readiness, program execution, and risk management across diagnostic manufacturing operations.

You will partner with R&D, Quality, Supply Chain and external partners to ensure campaigns are execution-ready, visible, scalable, and well controlled. The role demands strong engineering judgment, program leadership and experience in regulated life-science environments.

Qualifications

• PhD or higher in biotech/engineering/life sciences.
• 7+ years in manufacturing readiness or equivalent.
• Experience leading cross-functional teams in regulated diagnostics or life-science environments.
• Strong knowledge of GMP/GDP, ISO13485, change control and CAPA.

Responsibilities

• Represent Manufacturing in technical discussions on capability, readiness and timelines.
• Define business requirements for digital tools and workflows to improve traceability and visibility.
• Lead readiness reviews and elevate risks affecting quality, schedule or delivery.
• Coordinate readiness for new products transferred from R&D or external partners.
• Maintain manufacturing audit readiness and ensure retrievability of records and docs.
• Develop and monitor manufacturing metrics for sprint readiness, deviations and risk.
• Ensure procedures and batch records are identified and ready for execution.

Skills

PhD-level discipline

Cross-functional leadership

GMP/GDP/ISO13485 knowledge

Digital workflows/automation

Risk management

Audit readiness

Remote collaboration

Education

PhD in Biotechnology/Engineering/Life Sciences

Tools

Smartsheet

Jira

LIMS/MES

Dashboards

Job description

About our Company:

Universal D X, Inc. is an international Company with a highly experienced team focused on cracking cancer’s code. Through our multi-omics and bioinformatics models, we have figured out how to read the disease’s signals in blood with high accuracy to detect cancer in its earliest stages. Starting with a colorectal cancer screening liquid biopsy test, we are building a multi-cancer platform that can identify the unique DNA regions associated with different types of cancers.

The Opportunity:

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&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.

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”.

How you'll contribute:

• Represent Manufacturing in technical and operational discussions with internal customers and external partners regarding manufacturing capability, readiness, timelines, process implementation, and operational requirements.
• Define Manufacturing business requirements for Smartsheet, Jira, LIMS/MES, dashboards, and other digital tools. Develop scalable workflows that improve traceability, operational visibility, and execution.
• Lead post-sprint reviews, identify systemic issues and improvement opportunities, and convert lessons learned into sustainable improvements for future manufacturing campaigns.
• Maintain an integrated view of manufacturing milestones, dependencies, risks, and critical-path activities. Lead readiness reviews and elevation of risks that could affect quality, schedule, or delivery.
• Coordinate Manufacturing readiness for new products and processes transitioning from R&D, other sites, or external partners. Lead gap assessments, implementation planning, and execution readiness across equipment, materials, training, documentation, and operational requirements.
• 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.
• Develop and maintain meaningful Manufacturing metrics, including sprint readiness, schedule adherence, overdue actions, supplier readiness, documentation readiness, deviations, and recurring operational risks.
• 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.
• Facilitate structured readiness and decision-making forums, drive follow-through on action items, and provide clear status, risk, and escalation summaries to Manufacturing leadership.

What you'll bring:

• PhD in Biotechnology, Engineering, Life Sciences or a related technical discipline; advanced degree preferred.
• Typically 7+ years of industry experience in study design, documentation, manufacturing, diagnostic or biopharma, reagent manufacturing environments.
• Demonstrated experience leading cross-functional manufacturing readiness, technology transfer, new product introduction, or complex operational programs.
• Strong working knowledge of GMP/GDP principles, ISO 13485, change control, deviations/CAPA, training, equipment/material readiness, and manufacturing documentation.
• Experience translating operational needs into scalable digital workflows, dashboards, trackers, or LIMS/MES business requirements.
• Strong risk-management, problem-solving, facilitation, and executive communication skills with the ability to manage multiple interdependent priorities.
• Experience supporting audits or inspections and maintaining evidence-based manufacturing readiness.
• Ability to work effectively in a remote environment while maintaining strong engagement with Dallas-based Manufacturing operations and cross-functional partners.

What we’ll offer:

• 22 days of PTO with the possibility to carry over 10 days to the following year.
• Company Holidays, plus your Birthday off!
• Company-sponsored benefit plans, including medical, dental, and vision insurance plus life, STD, and LTD coverage, and 401(k).
• Flexible work schedule.
• And more to come!

Why Now?

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.

We are looking for passionate changemakers to be a part of our journey in this expansive time for us.