Senior Medical Device & Combo-Product Development Lead

Vertex Pharmaceuticals Incorporated; Boston (MA); Sur place; USD 172 000 - 258 000; Plein temps

Résumé du poste

Vertex is seeking an Associate Director for Medical Device & Combination Product Development to drive hands-on delivery-system programs from feasibility through commercialization readiness. This player-coach role integrates device engineering, software, human factors, quality, manufacturing, and regulatory strategy to deliver safe, reliable, patient-centered solutions.

You will mentor engineers, lead design controls with risk management per ISO 14971, and collaborate with QA, Regulatory,

Qualifications

• Experience in drug-delivery systems engineering.
• Proven ability to lead design controls and maintain DHF documentation.
• Strong understanding of ISO 13485 and ISO 14971 standards.

Responsabilités

• Lead device and combination-product development activities from feasibility through commercialization.
• Define integrated development strategies addressing requirements, usability, reliability, manufacturability, and regulatory expectations.
• Mentor and develop engineers while providing hands-on technical contributions.

Connaissances

Drug-delivery systems

Design controls

Systems engineering

Regulatory strategy

Risk management ISO14971

Software verification & validation

Electrical/mechanical development

Human factors usability

Software lifecycle

Team leadership

Formation

B.S or M.S in engineering

Experience in medical-device development

Description du poste

Vertex is seeking an Associate Director for Medical Device & Combination Product Development to drive hands-on delivery-system programs from feasibility through commercialization readiness. This player-coach role integrates device engineering, software, human factors, quality, manufacturing, and regulatory strategy to deliver safe, reliable, patient-centered solutions.

You will mentor engineers, lead design controls with risk management per ISO 14971, and collaborate with QA, Regulatory,