Medical Device & Combination Product Development, Associate Director

Vertex Pharmaceuticals

Vertex Pharmaceuticals seeks an Associate Director to lead drug-delivery device and combination-product development from feasibility through commercialization. This hands-on technical leader will integrate device engineering, software, human factors, and regulatory strategy to advance Vertex therapies.

Responsibilities

Lead device and combination-product development from feasibility through clinical development and commercialization readiness
Define integrated development strategies addressing product requirements, user needs, delivery performance, manufacturability, and regulatory expectations
Lead design-control activities including development plans, design inputs/outputs, traceability, design reviews, and Design History File documentation
Partner with human factors, quality, regulatory, clinical, and pharmaceutical sciences teams to ensure clinical-use readiness and lifecycle management
Mentor and develop engineers while providing hands-on technical contributions and clear accountability across matrixed teams

Requirements

B.S. or M.S. in engineering or relevant discipline; 10 years medical-device experience (8 with M.S., 6 with Ph.D.)
Demonstrated experience developing drug-delivery systems including infusion, wearable, on-body, or large-volume devices
Strong knowledge of ISO 13485, ISO 14971, FDA 21 CFR Part 4, and design-control processes including DHF documentation
Expertise in risk management including FMEAs, hazard analyses, and verification/validation test strategies
Working knowledge of connected and software-enabled device development, IEC 62304, and human factors engineering per IEC 62366-1
Experience managing external technical partners and leading matrixed teams in pharmaceutical or medical-device environments
Strong written, verbal, and presentation skills for communicating technical issues and product risks to diverse stakeholders

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Vacancy posted 5 days ago

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