Associate Director, Device Engineering
Core
Lead device engineering for drug-device combination product development, from concept through commercialization and sustaining, ensuring integration with CMC and product strategy.
Role type
Senior IC device engineering leader (combination products)
Builds
Drug delivery devices and packaging systems for immunology, hematology, cardiovascular, metabolic, respiratory, and transplant therapeutic areas
Domain
Biopharmaceuticals / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Drug-device combination product development, Design History File (DHF) management, risk management (hazard analysis, mitigation), supplier qualification, cross-functional program leadership, regulatory submission support, technology scouting, industry standards knowledge (ISO TCs, BioPhorum)
Preferred skills
Sustaining product development, matrix environment navigation, continuous improvement culture
Technologies
None explicitly listed
Responsibilities
Lead device engineering team and coordinate cross-functional inputs; Mentor team members on technical and leadership skills; Lead device selection, development, verification, validation, and supplier qualification; Translate user needs into product requirements and development plans; Lead risk management and control strategy implementation; Represent team on cross-functional program teams and manage workplans; Establish end-to-end capabilities and best practices; Track program timelines and risks; Monitor industry trends and regulatory guidance
Seniority
Senior, hands-on IC with leadership responsibilities
