Engineer III, Device Development
Core
Engineer III supporting technical design, development, and technology transfer for drug delivery devices and combination products.
Role type
Senior IC device development engineer
Builds
Drug delivery devices, combination products, and container closure systems
Domain
Biopharmaceuticals / Medical Devices
Deliverable
product features
Required skills
Design control, mold and fixture design, validation processes (IQ/OQ/PQ), CAE, mechanical/electromechanical testing, regulatory compliance (FDA QSR 21 CFR Part 4, 820, ISO13485)
Preferred skills
Injector-based combination product experience, 4-6 years in medical device development
Technologies
CAE, bench top models, production representative units
Responsibilities
Support device development activities for combination products, collaborate with device partners on design verification, assess container closure systems, conduct characterization and testing, liaise with third-party manufacturers, align with quality assurance and regulatory requirements
Seniority
Mid-level IC (4-6 years experience preferred)