Sr. Engineer - Combination Product Inhalation Device Lead

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, 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.

Responsibilities

• 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 drug-device-capsule integration, defining and managing critical interfaces among the dry-powder drug product, capsule, inhaler, and user to achieve reliable dose delivery and aerosol performance.
• Assess supplier technical evidence and MAF applicability, identify evidence gaps and bridging needs, and provide technical oversight of device suppliers, including design changes, investigations, verification evidence, and lifecycle support.
• Coordinate with regulatory, quality, drug product, analytical, manufacturing, clinical, human factors, suppliers, and other cross-functional stakeholders to support technical decisions, submissions, issue resolution, and lifecycle changes.

Basic Qualifications

• Doctorate degree OR
• Master’s degree and 2 years of Engineering experience OR
• Bachelor’s degree and 4 years of Engineering experience OR
• Associate’s degree and 8 years of Engineering experience OR
• High school diploma / GED and 10 years of Engineering experience

Preferred Qualifications

• Direct experience developing capsule-based or other dry powder inhaler platforms and combination products from early development through design verification and regulatory submission.
• Experience with aerosol performance characterization and methods such as delivered dose uniformity, aerodynamic particle size distribution, device resistance/pressure-flow characterization, or related inhalation testing.
• Experience assessing supplier design-history, verification, manufacturing, and master-file evidence, including applicability/bridging decisions and letters of authorization where applicable.
• Experience supporting FDA or global regulatory submissions for drug-device combination products, including technical responses, design-control evidence, and device constituent documentation.
• Experience providing technical oversight of external device suppliers and leading cross-functional resolution of device performance, integration, manufacturing, or lifecycle issues.
• Knowledge of fluid dynamics, aerosol science, particle dispersion/deagglomeration, or modeling approaches relevant to DPI device performance.
• Experience with platform-device strategies, configuration/change control, and risk-based bridging of device evidence across products or presentations.
• Experience providing technical mentoring or serving as a subject matter expert in combination-product systems engineering, device development, or inhalation delivery systems.