Medical Device & Combination Product Development, Associate Director

Vertex Pharmaceuticals • Boston, MA

2d • $172,200 - $258,400 • Onsite

About The Position

The Medical Device & Combination Product Development, Associate Director is a hands-on technical leader responsible for advancing drug-delivery device and combination-product programs supporting Vertex therapies. This player-coach role leads development of mechanical, electromechanical, wearable, on-body, and connected delivery systems, integrating device engineering, software, human factors, clinical needs, quality requirements, manufacturing considerations, and regulatory strategy to deliver safe, reliable, patient-centered solutions from feasibility through commercialization readiness.

The role provides technical leadership across device architecture, delivery performance, connectivity, user interfaces, accessories, design controls, risk management, and verification and validation. It collaborates with internal functions and external partners, supports clinical-use readiness, and mentors engineers and technical staff while remaining accountable for hands-on technical contributions across matrixed teams.

Requirements

• B.S. or M.S. in engineering or another relevant discipline, with at least 10 years of experience working in a medical-device development environment; the experience requirement is 8 years with an M.S. or 6 years with a Ph.D.
• Relevant industry experience in medical-device, drug-delivery, digital, and drug-device combination-product development.
• Demonstrated experience developing drug-delivery systems, including infusion, wearable, on-body, and/or large-volume delivery devices.
• Experience leading medical-device and combination-product design controls, including requirements management, traceability, Design History File documentation, and design-change control.
• Strong knowledge of drug-device system architecture and requirements engineering.
• Deep working knowledge of ISO 13485 quality-management systems, ISO 14971 risk management, FDA combination-product requirements under 21 CFR Part 4, and applicable FDA medical-device quality-system requirements.
• Experience developing and executing design verification, design validation, and risk-based test strategies, including reliability, robustness, environmental, transportation, and delivery-performance testing.
• Experience in mechanical and electromechanical device development.
• Experience with human factors and usability engineering, including IEC 62366-1, formative and summative evaluations, use-related risk analysis, and clinical-use device readiness.
• Demonstrated expertise in risk-management activities, including FMEAs, hazard analyses, and risk-control verification.
• Working knowledge of connected and software-enabled medical-device development, including software verification and validation, cybersecurity risk management, software lifecycle oversight, software change control, and familiarity with IEC 62304.
• Experience working in a matrixed pharmaceutical, biotechnology, medical-device, or digital-health environment.
• Experience managing external technical partners, including development partners, suppliers, CROs, test laboratories, and contract manufacturers.
• Strong written, verbal, and presentation skills, including the ability to communicate complex technical issues, development status, and product risks clearly to technical and nontechnical stakeholders.
• Experience leading, mentoring, and developing engineers or technical staff.

Nice To Haves

• Advanced degree in a technical, scientific, engineering, or business discipline.
• Experience supporting clinical studies for investigational devices or drug-device combination products.
• Experience supporting FDA combination-product regulatory strategy and submissions, including IND, BLA, NDA, CTA, IMPD, MAA, or related filings.
• Experience with medical-device software lifecycle processes, software validation, mobile and cloud-service validation, and cybersecurity principles.
• Experience with electrically powered, battery-operated, sensor-enabled, or electronically controlled delivery systems.
• Familiarity with IEC 60601-series standards.
• Experience developing patient-facing, home-use, or self-administered delivery systems.
• Experience supporting global development programs and international regulatory submissions.

Responsibilities

• Lead device and combination-product development from early feasibility through clinical development and commercialization readiness.
• Define integrated development strategies covering requirements, user needs, delivery performance, usability, reliability, manufacturability, and regulatory expectations.
• Translate intended use, clinical requirements, and user needs into system, software, interface, and component design inputs.
• Provide technical leadership for device architecture, delivery performance, connectivity, user interfaces, and accessories.
• Lead design-control activities, including development plans, design inputs and outputs, traceability, design reviews, verification and validation, risk management, design changes, and Design History File documentation.
• Apply risk-management principles, including hazard analyses, FMEAs, use-related risk analyses, risk controls, and benefit-risk assessments.
• Develop and oversee risk-based verification and validation strategies for functional, mechanical, electrical, software, transportation, reliability, compatibility, and delivery-performance testing.
• Partner with Human Factors and Usability Engineering to plan and execute formative and summative usability evaluations.
• Support clinical-use readiness through device configuration, labeling, instructions for use, packaging, training materials, clinical documentation, and complaint workflows.
• Partner with suppliers to integrate design and development activities for connected drug-delivery systems.
• Ensure lifecycle, interoperability, and change-control requirements are incorporated throughout development.
• Collaborate with Quality Assurance, Regulatory Affairs, Clinical, Pharmaceutical Sciences, and Drug Product Development teams.
• Manage external technical partners, including development partners, suppliers, CROs, test laboratories, and contract manufacturers.
• Mentor and develop engineers and technical staff while providing hands-on technical contributions and accountability across matrixed teams.
• Communicate technical issues, development status, and product risks to technical and nontechnical stakeholders.

Benefits

• Annual bonus and annual equity awards.
• Medical, dental, and vision benefits.
• Generous paid time off, including a week-long company shutdown in the summer and winter.
• Educational assistance programs, including student loan repayment.
• Commuting subsidy.
• Matching charitable donations.
• 401(k).

What This Job Offers

• Job Type: Full-time
• Career Level: Director