Job Description
As a Senior IVD Systems Engineer, you will work closely with R&D teams to design, define, manage, and document systems consisting of laboratory developed tests for cancer diagnostics throughout the development lifecycle, as well as supporting FDA submissions within an IVD framework. In this role, you’ll have the opportunity to collaborate with functional leaders in software, bioinformatics, assay development, lab automation, sequencing, and cancer screening to support design, integration and documentation from sample receipt to clinical report generation. You’ll take leadership role within the Systems engineering team to spearhead all regulatory aspects of technical projects.
We’ll look to you to optimize and integrate complex and multi-variate problems at the interface of laboratory automation, process engineering, molecular biology, regulatory and operations. You’ll influence and guide your colleagues to integrate the QSR mindset into their day-to-day and build efficient workflows that enable the team to navigate the regulatory environment while maintaining momentum.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Qualifications
Additional Information
All your information will be kept confidential according to EEO guidelines.
#preventivemedicine #team #cancer #clinicaltrial #cancertreatment #hematology #cancertherapy #NGS #GuardantHealth #PatientFirst #LiquidBiopsy #LUNAR #Eclipse #RealWorldEvidence #CDx #CompanionDiagnostics #biojobs #biotechjobs #biotechcareers #biocareers #pharmajobs #oncologyjobs #biotechbay #LI-CM1