Senior DPI Device Engineer - Lead, Drug-Device Integration

Amgen SA; Thousand Oaks (CA); On-site; USD 140,000 - 210,000; Full time

Benefits offered by this job

Flexible work models

Retirement and Savings Plan

Medical/dental/vision coverage

Job summary

Amgen in Thousand Oaks seeks an experienced Sr. Engineer to lead the design and development of dry powder inhaler (DPI) combination products within the CPD&T organization.

You will translate user needs into robust device requirements, interfaces, and verification strategies to deliver patient-centric dose delivery. The role requires leading DHF/DDP activities, supervising supplier integration and bridging evidence, and collaborating with regulatory, quality, and manufacturing teams to ensure

Qualifications

• Doctorate degree
• Master’s degree with 2 years engineering experience
• Bachelor’s degree with 4 years engineering experience
• Associate’s degree with 8 years engineering experience
• High school diploma / GED with 10 years engineering experience
• Direct experience developing capsule-based or other dry powder inhaler platforms
• Experience with aerosol performance characterization and methods (delivered dose, particle size, device resistance)
• Experience assessing supplier design-history, verification, and master-file evidence
• Experience supporting FDA or global regulatory submissions for drug-device products
• Experience providing technical oversight of external device suppliers
• Knowledge of fluid dynamics, aerosol science, and particle dispersion relevant to DPI performance
• Experience with platform-device strategies, configuration/change control, and risk-based bridging of device evidence
• Experience providing technical mentoring as a subject matter expert in combination-product systems engineering

Responsibilities

• Lead combination-product systems engineering and device development for DPI programs, including architecture and interface definition
• Own DHF/DDP deliverables for the DPI device and ensure design-control documentation is complete and traceable
• Establish end-to-end traceability from user needs to verification and evidence
• Develop the design verification strategy for the DPI device and integrated product
• Apply inhalation fundamentals in partnership with analytics and methods teams
• Lead drug-device-capsule integration ensuring reliable dose delivery and aerosol performance
• Assess supplier evidence and provide technical oversight of device suppliers
• Coordinate with regulatory, quality, manufacturing, clinical, human factors, and other teams to support decisions and lifecycle changes
• Collaborate with cross-functional stakeholders to integrate device performance into the product development strategy
• Provide technical mentoring and SME input on combination-product systems engineering

Skills

DPI platforms

Aerosol testing

Regulatory submissions

Supplier oversight

Fluid dynamics

Inhalation science

Platform-device strategy

Mentoring/SME

Education

Doctorate degree

Master’s degree + 2 years engineering

Bachelor’s degree + 4 years engineering

Associate’s degree + 8 years engineering

High school diploma + 10 years engineering

Job description

Amgen in Thousand Oaks seeks an experienced Sr. Engineer to lead the design and development of dry powder inhaler (DPI) combination products within the CPD&T organization.

You will translate user needs into robust device requirements, interfaces, and verification strategies to deliver patient-centric dose delivery. The role requires leading DHF/DDP activities, supervising supplier integration and bridging evidence, and collaborating with regulatory, quality, and manufacturing teams to ensure