Senior Engineer II, Device Development
Core
Design, development, and lifecycle management of patient-centric drug delivery devices and combination products.
Role type
Senior IC device development engineer (combination products)
Builds
Drug delivery devices (autoinjectors, pre-filled syringes, wearable injectors, pen injectors) and combination products
Domain
Medical devices / Drug delivery systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biomedical/electrical/mechanical engineering, drug delivery device development, risk management (ISO 14971), regulatory compliance (21 CFR, ISO 13485), design history file management, root cause analysis, supplier management, verification and validation planning, project planning
Preferred skills
Requirements/risk management traceability tools (JAMA DOORS, Polarion, CodeBeamer), AI integration, electromechanical device R&D, Design of Experiments, Design for Six Sigma, Design for Manufacturing
Technologies
JAMA DOORS, Polarion, CodeBeamer, FEA, CAD (implied by modeling/prototyping)
Responsibilities
Develop and maintain Design History File content; support risk management and author risk-based verification plans; lead technical investigations and root cause analysis; support design changes and lifecycle management; control device constituent part development; oversee verification activities at contract laboratories; contribute to regulatory filings
Seniority
Senior, hands-on IC
