Staff Engineer, Systems Integration
Core
Lead system integration, verification and validation (V&V), and design feasibility assessment for In Vitro Diagnostics (IVD) medical devices from concept to manufacturing.
Role type
Staff Engineer, Systems Integration (IVD Medical Devices)
Builds
IVD medical device systems and product lines
Domain
Healthcare / Medical Devices / In Vitro Diagnostics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
System integration, V&V, requirements traceability, system architecture definition, Design of Experiment (DOE), failure analysis (FMEA/HA), cross-functional collaboration, technical writing, root cause analysis
Preferred skills
Instrument automation, Six Sigma/DFSS, formal requirements management tools, next generation sequencing, immuno-histochemistry, PCR, methylation, model-based system engineering
Technologies
DOE, FMEA, HA, DHF, requirements management tools
Responsibilities
Lead system integration activities during product design and V&V phases; Assess design feasibility and test product functionality; Responsible for test method development and V&V activities at the system level; Participate in new product design and design improvements; Engage with OEMs for technical oversight; Collaborate with hardware, software, and reagent teams; Participate in product risk management activities (HA, FMEA); Assist in manufacturing process development and troubleshooting.
Seniority
Staff, hands-on IC with strategic influence
