Engineer – Combination Product Development, Prefilled Syringe (PFS) Platform
Core
Engineer leading cross-functional teams to develop, verify, and transfer prefilled syringe (PFS) platform technologies for combination products.
Role type
Senior IC combination product development engineer (medical devices)
Builds
Reusable PFS platform technologies, device and packaging solutions for combination products
Domain
Biopharmaceuticals / Medical Devices
Required skills
Engineering fundamentals, cross-functional team leadership, technical documentation, test protocol execution, data analysis, risk management, design transfer coordination, project management, root-cause analysis
Preferred skills
Experience with prefilled syringes/injection devices, design controls, electronic document management, statistical sampling, project management practices
Technologies
Electronic document management systems, laboratory notebook systems, project tracking systems
Responsibilities
Lead cross-functional technical teams for product and platform development; Develop and maintain technical work plans and risk tracking; Execute engineering tests for devices and packaging; Draft design-control records and risk assessments; Analyze test data and identify trends; Coordinate with human factors, quality, and regulatory functions; Support design transfer and site implementation; Investigate device issues and document findings.
Seniority
Mid-to-Senior, hands-on IC with team leadership
