Device Engineer III
Core
Support commercialization and sustaining engineering for drug-device combination products from design transfer through ongoing commercial support.
Role type
Senior IC device engineer (combination products)
Builds
Drug-device combination products for commercial markets
Domain
Biopharmaceuticals / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design controls, risk management, change management, complaint management, ISO 13485, ISO 14971, design transfer, vendor management, process characterization, statistical analysis
Preferred skills
Mechanical assembly processes for drug injection/delivery, Solidworks/Onshape/Fusion 360, ICH Q7/Q8/Q9/Q10, project management, design of experiments
Technologies
Solidworks, Onshape, Fusion 360
Responsibilities
Represent Device Development on commercial CMC and business continuity teams; Implement post-launch changes and support complaint handling/investigations; Perform risk management reviews per ISO 14971; Maintain Design History File (DHF); Support business continuity and manufacturing site selection; Execute design transfer activities; Author and review technical documentation including design control records and risk management docs
Seniority
Senior, hands-on IC
