Device Manager (Cell Therapy Combination Product)

Neurona Therapeutics•South San Francisco, CA

7d•Onsite

About The Position

Neurona Therapeutics is seeking an experienced, self-motivated Device Manager to join its Translational Medicine Cell Delivery Team. The role provides end-to-end technical and operational leadership for the evaluation, selection, development, qualification, clinical implementation, and commercialization of devices used to prepare and deliver cell therapies. The goal is to ensure that the device, cell product, procedures, labeling, and user interface function safely and effectively as an integrated combination product. The Device Manager manages device development projects, establishes and maintains design controls and device documentation, coordinates verification and validation activities, and supports regulatory submissions and commercial readiness. The position works independently and collaboratively with internal cross-functional teams and external device manufacturers. It is based on-site at Neurona’s South San Francisco office and reports to the Head of Cell Delivery.

Requirements

Bachelor’s or master’s degree in Biomedical Engineering, Mechanical Engineering, Bioengineering, or a related engineering or scientific discipline.
At least 7 years of relevant experience in medical device development, biotechnology, pharmaceuticals, or related regulated industries.
Demonstrated experience managing medical device development projects, including cross-functional teams, external manufacturers, and project deliverables.
Strong knowledge and hands-on experience with medical device design controls, Design History Files, device verification and validation, and risk management.
Experience in regulated device and combination product quality systems, including FDA Quality Management System Regulation under 21 CFR Part 820, 21 CFR Part 4, ISO 13485, and ISO 14971.
Experience developing and maintaining device technical documentation, including specifications, engineering protocols, verification and validation reports, and risk assessments.
Understanding of medical device and combination product regulatory requirements, including supporting submissions and device regulatory strategies.
Experience with human factors engineering, usability evaluations, and use-related risk management.
Ability to independently manage complex projects, prioritize competing activities, and deliver within established timelines.
Strong technical writing, organizational, communication, and presentation skills, including the ability to communicate complex technical information to cross-functional teams and management.
Exceptional organizational and time management skills and ability to work effectively in a fast-paced, dynamic environment.
Self-motivation, initiative, problem-solving skills, and ability to work independently and collaboratively.

Nice To Haves

Experience working with original equipment manufacturers, contract manufacturers, and external device development partners.
Experience with drug-device or biologic-device combination products.
Experience with infusion pumps, syringe-based delivery systems, surgical devices, or other drug delivery technologies.
Experience developing or qualifying devices for cell or gene therapy preparation and delivery, with an understanding of clinical workflows and product quality considerations.
Experience supporting medical device development from clinical-stage use through commercial launch.
Knowledge of FDA 21 CFR Part 4, EU MDR, ISO 62366-1, and applicable international combination product regulatory requirements.
Experience preparing device-related CMC documentation and supporting combination product regulatory submissions, including BLAs and marketing authorization applications.

Responsibilities

Manage device development projects supporting the cell therapy combination product program, including device evaluation, selection, development, qualification, and commercialization.
Develop and maintain project plans, timelines, milestones, and deliverables for clinical development and commercial readiness.
Identify and evaluate device technologies, components, and external manufacturers for cell preparation and delivery needs.
Coordinate work among Cell Delivery, Quality, Regulatory Affairs, CMC, and external device manufacturers.
Establish and maintain design controls, including user needs, system-level requirements, design inputs and outputs, specifications, design reviews, and bidirectional traceability.
Develop and maintain Design History Files and other device technical documentation.
Coordinate device risk management under ISO 14971, including assessments, mitigation strategies, and documentation.
Lead or coordinate use-related risk analyses, human factors studies, and usability evaluations for the combination product workflow.
Support device verification and validation, including functional, performance, reliability, and compatibility testing.
Develop and execute device and cell product compatibility studies assessing effects on cell quality, viability, and dose accuracy.
Develop and execute device qualification and validation strategies for intended clinical-use conditions.
Collaborate with Regulatory Affairs on device regulatory strategies and technical documentation for regulatory submissions, including INDs, BLAs, and international marketing applications.
Ensure device development activities and documentation comply with applicable FDA regulations, ISO 13485, and other relevant requirements.
Support device-related change controls, technical assessments, investigations, and continuous improvement.
Support design transfer, manufacturing readiness, and lifecycle management for commercialization.
Prepare and review technical documentation, including protocols, reports, specifications, procedures, risk assessments, and submission materials.
Support clinical device implementation, including configuration, readiness, troubleshooting, complaint investigations, and collection of performance and usability feedback.
Present project updates, technical assessments, and development progress to cross-functional teams and management.
Identify technical, quality, and regulatory risks and develop mitigation strategies.
Take ownership and follow through to complete responsibilities and project deliverables on time.