On-Site Associate Director, Med Device & Combo-Product Development

Vertex Pharmaceuticals LLC; Boston (MA); Hybrid; USD 172,000 - 258,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Commuting subsidy

Generous PTO

Job summary

Vertex Pharmaceuticals seeks an Associate Director for Medical Device & Combination Product Development to lead hands-on, systems-level design across mechanical, electrical, software, and human factors domains. The role saturates clinical needs, regulatory strategy, and manufacturing considerations from feasibility through commercialization readiness.

You will drive design controls, risk analyses (FMEAs), verification/validation, and cross-functional collaboration with QA, Regulatory, and

Qualifications

• B.S. or M.S. in engineering or related field and a minimum of 10 years in medical device/drug-delivery development (8y with M.S., 6y with Ph.D.).
• Experience leading medical-device and combination-product design controls, including requirements management, traceability, DHF documentation, and design-change control.
• Hands-on leader capable of integrating device engineering, software, human factors, quality, and regulatory strategy from feasibility to commercialization readiness.

Responsibilities

• Lead device and combination-product development from early feasibility to clinical development and commercialization readiness.
• Define integrated development strategies addressing requirements, usability, reliability, manufacturability, and regulatory expectations.
• Mentor and develop engineers while delivering hands-on technical contributions across matrixed teams.

Skills

Device development

Risk management

Design controls

ISO 13485

Software verification

Regulatory strategy

Education

Engineering degree

Tools

IEC 60601 standards

IEC 62304

ISO 14971

Job description

Vertex Pharmaceuticals seeks an Associate Director for Medical Device & Combination Product Development to lead hands-on, systems-level design across mechanical, electrical, software, and human factors domains. The role saturates clinical needs, regulatory strategy, and manufacturing considerations from feasibility through commercialization readiness.

You will drive design controls, risk analyses (FMEAs), verification/validation, and cross-functional collaboration with QA, Regulatory, and