Sr. Engineer - Combination Product Inhalation Device Lead

Amgen · Cambridge, MA +1 more

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Role summary

Senior engineer position leading systems engineering and device development for dry powder inhaler combination products at Amgen. The role involves design controls, requirements engineering, supplier oversight, and cross-functional collaboration to deliver integrated drug-device-capsule solutions.

What they're looking for

Doctorate degree, or Master's with 2+ years engineering experience, or Bachelor's with 4+ years engineering experience
Direct experience developing dry powder inhaler platforms and combination products
Expertise in design controls, requirements engineering, and Design History File activities
Knowledge of inhalation fundamentals including device resistance, airflow, and aerosolization
Experience with supplier technical assessment and design verification strategies
Strong cross-functional collaboration and regulatory/quality integration skills

What you'll be doing

Lead systems engineering and device development for DPI combination product programs
Own Design History File and Design and Development Plan deliverables for DPI device constituent
Establish and maintain traceability from user needs through design outputs and verification evidence
Develop and execute design verification strategies including supplier evidence assessment and bridging needs
Coordinate with regulatory, manufacturing, clinical, and cross-functional teams on technical decisions and lifecycle support

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