Staff Manufacturing Engineer - Remote Diagnostics Leader
Universal Diagnostics
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Benefits offered by this job
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
Education
Tools
Job description
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.
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