Medical Device & Combination Product Development, Associate Director

** Job Description
**** General

Summary:

** 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.
** Key

Duties and 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.
** Knowledge and

Skills:

*** 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…