Medical Device & Combination Product Development, Associate Director

Vertex Inc.•Boston, MA

1d•$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 the development of mechanical, electromechanical, wearable, on-body, and connected delivery systems. The successful candidate will integrate 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.

Requirements

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 (DHF) 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, with the ability to clearly communicate complex technical issues, development status, and product risks to technical and nontechnical stakeholders.
Experience leading, mentoring, and developing engineers or technical staff.
B.S or M.S in engineering or another relevant discipline and a minimum of 10 years of experience (8 years with M.S., 6 years with Ph.D.) working within a medical device development environment
Relevant industry experience in medical-device, drug-delivery, digital, and drug-device combination-product development.

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 activities from early feasibility through clinical development and commercialization readiness.
Define integrated development strategies that address product requirements, user needs, delivery performance, usability, reliability, manufacturability, and regulatory expectations.
Translate intended use, clinical requirements, and user needs into clear 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 in accordance with ISO 14971, 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, including device configuration, labeling, instructions for use, packaging, training materials, clinical documentation, and complaint workflows.
Partner with suppliers to integrate design and development activity 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.
Mentor and develop engineers and technical staff while providing hands-on technical contributions and clear accountability across matrixed teams.