Associate Director, Medical Device & Combo-Product Development

MFS Investments; Boston, Northern (MA, KY); Hybrid; USD 172,000 - 258,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Comprehensive benefits

Job summary

Vertex Pharmaceuticals is seeking an Associate Director for Medical Device & Combination Product Development in Boston to lead hands-on engineering across mechanical, electromechanical, wearable and connected delivery systems. You will integrate device engineering, software, usability, regulatory strategy and manufacturing considerations from feasibility through commercialization readiness.

The role requires a strong background in drug-delivery devices, design controls, risk management and

Qualifications

• B.S. or M.S. in engineering with 10+ years in medical device development (8+ years with M.S., 6+ with Ph.D.).
• Experience leading device and combination-product design controls (requirements, traceability, DHF, design changes).
• Strong knowledge of ISO 13485, ISO 14971, and FDA combination-product requirements.
• Proven track record in risk-based testing strategies and design verification/validation.
• Experience with software-enabled medical devices and cybersecurity concepts.

Responsibilities

• Lead device and combination-product development from feasibility to commercialization readiness.
• Define integrated development strategies addressing requirements, usability, and regulatory expectations.
• Oversee risk management activities, verification, validation, and design-history-file documentation.
• Collaborate with Human Factors, QA, Regulatory, and Clinical teams to ensure interoperability and lifecycle control.
• Mentor engineers and manage external partners and suppliers as needed.

Skills

Drug-delivery systems

Device architecture

Risk management (ISO 14971)

Design controls (DHF, traceability)

Software verification & validation

Systems engineering

Leadership & mentorship

Education

B.S. or M.S. in engineering

Tools

IQM/ISO 13485 familiarity

IEC 62304 familiarity

Job description

Vertex Pharmaceuticals is seeking an Associate Director for Medical Device & Combination Product Development in Boston to lead hands-on engineering across mechanical, electromechanical, wearable and connected delivery systems. You will integrate device engineering, software, usability, regulatory strategy and manufacturing considerations from feasibility through commercialization readiness.

The role requires a strong background in drug-delivery devices, design controls, risk management and