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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in systems engineering and device development for dry powder inhalers, with a strong focus on regulatory submissions, aerosol performance characterization, and technical oversight of suppliers. Proficient in translating user needs into design requirements and managing cross-functional collaboration for successful product integration.
Highest-signal resume keywords
Systems EngineeringAerosol Performance CharacterizationRegulatory SubmissionsTechnical Oversight of SuppliersDevice Development
ATS Keywords
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Hard Skills
Design History File ManagementRequirements EngineeringDesign Verification StrategyConfiguration ManagementRisk-Based BridgingFluid Dynamics KnowledgeAerosol Science ExpertiseInhalation Testing MethodsDevice Resistance CharacterizationTechnical Mentoring
Soft Skills
Cross-Functional CollaborationTechnical Decision-MakingIssue Resolution
Industry Keywords
Dry Powder InhalerCombination ProductsDrug-Device IntegrationUser Needs TranslationDesign OutputsSupplier Design AssessmentChange ControlDevice Performance ModelingMaster-File EvidenceStakeholder Coordination
About the role
Key responsibilities & impact- Lead systems engineering and device development activities for dry powder inhaler combination products
- Translate user and patient needs and product objectives into system and device requirements, interface definitions, design outputs, verification strategies, and integrated drug-device-capsule solutions
- Own and drive Design History File and Design and Development Plan activities for the DPI device constituent
- Lead needs and requirements engineering, system and subsystem interface definition, design reviews, design verification strategy, configuration management, and change control
- Apply EDDO / delivery-output thinking to control device outputs important to dose delivery, aerosolization, usability, and combination-product performance
- Maintain traceability from needs and requirements through risk controls, design outputs, verification, and supporting evidence
- Lead technical integration of supplier-provided DPI platforms and evidence
- Assess supplier design, verification, manufacturing, and master-file evidence; identify gaps and bridging needs
- Provide technical oversight of device suppliers, including design changes, investigations, verification evidence, and lifecycle support
- Partner with combination product SMEs and drug product, analytical, regulatory, quality, manufacturing, clinical, human factors, and other development teams
- Lead drug-device-capsule integration and manage critical interfaces among the dry-powder drug product, capsule, inhaler, and user
- Coordinate cross-functional stakeholders to support technical decisions, submissions, issue resolution, and lifecycle changes
Requirements
What you’ll need- 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
- 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
- Experience providing technical oversight of external device suppliers
- 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
- Experience providing technical mentoring or serving as a subject matter expert in combination-product systems engineering, device development, or inhalation delivery systems
Benefits
Comp & perks- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- A discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
- Career development opportunities
- Work/life balance
- Financial plans with opportunities to save towards retirement or other goals