Staff Systems & Failure Investigation Engineer
Core
Develop test processes, manage suppliers, and lead failure investigations for diagnostic instruments and manufacturing systems.
Role type
Staff Systems & Failure Investigation Engineer
Builds
Diagnostic instruments and manufacturing test processes for life sciences and biotechnology
Domain
Life sciences, diagnostics, biotechnology, manufacturing engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
global manufacturing operations, system integration, component/module assembly, Lean Manufacturing, cGMP/ISO/FDA compliance, statistical analysis, data management, business intelligence analytics, cross-functional leadership
Preferred skills
none stated
Technologies
none stated
Responsibilities
Develop and improve functional and system-level test processes for manufacturing; Partner with design teams to define test parameters and execute quality assurance procedures; Oversee contract manufacturing partners for sustaining and new product introduction programs; Manage supplier performance by monitoring test yield and analyzing complex datasets; Lead failure investigations from production or field issues, design and execute experiments, and coordinate cross-functional responses
Seniority
Staff, hands-on IC with strategic oversight
