Sr. Engineer - Combination Product Inhalation Device Lead

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnesses drives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.

As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Lets do this. Lets change the world. In this vital role you will join the Combination Product Development and Transformation (CPD&T) team to lead systems engineering and device development activities for dry powder inhaler (DPI) combination products. In support of Amgen's mission to serve patients, the CPD&T team develops drug-device combination products to support Amgens portfolio of drugs and biologics for patient-centric drug delivery.

The Sr. Engineer will provide technical leadership across combination-product design controls, translating user and patient needs and product objectives into robust system and device requirements, interface definitions, design outputs, verification strategies, and integrated drug-device-capsule solutions.

The Sr. Engineer will own and drive key Design History File (DHF) and Design and Development Plan (DDP) activities for the DPI device constituent, including needs and requirements engineering, system and subsystem interface definition, design reviews, design verification strategy, configuration management, and change control. The role will apply EDDO / delivery-output thinking to identify and control the device outputs most important to dose delivery, aerosolization, usability, and overall combination-product performance, and will maintain clear traceability from needs and requirements through risk controls, design outputs, verification, and supporting evidence.

The Sr. Engineer will also lead technical integration of supplier-provided DPI platforms and evidence. This includes assessing the applicability of supplier design, verification, manufacturing, and master-file (MAF) evidence; identifying gaps and appropriate bridging needs; and providing technical oversight of device suppliers. The role will partner closely with other combination product SMEs, as well as drug product, analytical and methods, regulatory, quality, manufacturing, clinical, human factors, and other development teams to integrate DPI device design and airflow characteristics, aerosolization fundamentals, capsule-device interactions, and drug-device-capsule performance into the product development strategy.

• Lead combination-product systems engineering and device development for DPI programs, including system architecture, needs and requirements engineering, interface definition, technical trade-offs, integration planning, and design reviews.
• Own or lead DHF/DDP deliverables for the DPI device constituent and ensure design-control documentation is complete, coherent, configuration-controlled, and aligned with the evolving combination-product design.
• Establish and maintain end-to-end traceability among user and product needs, system and device requirements, EDDO / delivery outputs, risk controls, design outputs, verification activities, and objective evidence.
• Develop the design verification strategy for the DPI device and integrated combination product, including rationale for use of supplier evidence, platform knowledge, bridging, analysis, and product-specific testing.
• Apply DPI platform knowledge and inhalation fundamentals, including device resistance, airflow, aerosolization and powder-dispersion behavior, in partnership with analytical and methods teams to support device selection, development, and performance understanding.
• Lead…