Associate Director, Drug-Delivery Device Innovation

Vertex Pharmaceuticals Inc (US); United States; On-site; USD 183,000 - 248,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Paid time off

Educational assistance

Commuting subsidy

401(k) and equity

Job summary

Vertex Pharmaceuticals in the United States seeks an Associate Director to lead drug-delivery device and combination-product programs from feasibility to commercialization readiness. This hands-on role integrates device engineering, software, human factors, clinical needs, and regulatory strategy to deliver safe, reliable, patient-centered solutions.

The role requires deep experience in device architecture, risk management (FMEA, ISO 14971), and regulatory submissions across FDA pathways, with

Qualifications

• Minimum of 10 years in medical device development (8 years with MS, 6 years with PhD).
• BS or MS in engineering or related discipline required.

Responsibilities

• Lead device and combination-product development from feasibility to commercialization.
• Define integrated development strategies addressing requirements, usability, reliability, manufacturability, and regulatory expectations.
• Translate clinical requirements and user needs into system, software, interface, and component design inputs.
• Provide technical leadership for device architecture and delivery performance.
• Lead design-control activities including DHF documentation and risk management.

Skills

Drug-delivery systems

Design controls

Systems engineering

Regulatory knowledge

Risk management

Software verification

Leadership

Matrix collaboration

Education

Bachelor's or Master's in engineering

Tools

IEC 62304

ISO 13485

FDA 21 CFR Part 4

IEC 60601

Job description

Vertex Pharmaceuticals in the United States seeks an Associate Director to lead drug-delivery device and combination-product programs from feasibility to commercialization readiness. This hands-on role integrates device engineering, software, human factors, clinical needs, and regulatory strategy to deliver safe, reliable, patient-centered solutions.

The role requires deep experience in device architecture, risk management (FMEA, ISO 14971), and regulatory submissions across FDA pathways, with