Device Manager (Cell Therapy Combination Product)
Posted
Device Manager (Cell Therapy Combination Product)
Location: South San Francisco, CA, 94080
Job Type: Full Time
Work Type: On-Site
Neurona Therapeutics is a clinical-stage biotechnology company based in South San Francisco focused on the development of cell-based therapies for neurological diseases.
We are seeking an experienced, self-motivated Device Manager to join our Translational Medicine Cell Delivery Team. The ideal candidate will have a strong background in medical device and combination product development, project management, device quality systems, and global regulatory requirements. This individual will provide end-to-end technical and operational leadership for the evaluation, selection, development, qualification, clinical implementation, and commercialization of devices used in the preparation and delivery of cell therapies, ensuring that the device, cell product, procedures, labeling, and user interface function safely and effectively as an integrated combination product.
The successful candidate will be responsible for managing device development projects, establishing and maintaining design controls and device documentation, coordinating verification and validation activities, and supporting regulatory submissions and commercial readiness. This position requires strong technical writing, organizational, and project management skills, as well as the ability to work independently and collaborate effectively with internal cross-functional teams and external device manufacturers.
This is an on-site position based at Neurona's South San Francisco office, reporting to the Head of Cell Delivery.
Key Responsibilities
- Manage device development projects supporting Neurona's cell therapy combination product program, including device evaluation, selection, development, qualification, and commercialization activities.
- Develop and maintain device development project plans, timelines, milestones, and deliverables to support clinical development and commercial readiness.
- Identify and evaluate new device technologies, components, and external manufacturers to support cell preparation and delivery requirements.
- Coordinate cross-functional activities with Cell Delivery, Quality, Regulatory Affairs, CMC, and external device manufacturers to ensure timely execution of device development activities.
- Establish and maintain device design controls, including user needs, system-level requirements, design inputs and outputs, device specifications, design reviews, and bidirectional traceability linking requirements, risk controls, verification and validation evidence, labeling, and regulatory commitments.Develop and maintain Design History Files (DHF) and other device technical documentation in accordance with applicable quality and regulatory requirements.
- Coordinate device risk management activities in accordance with ISO 14971, including risk assessments, risk mitigation strategies, and risk management documentation.
- Lead or coordinate use-related risk analyses, formative and summative human factors studies, and usability evaluations for the complete combination product workflowSupport the development and execution of device verification and validation activities, including functional, performance, reliability, and compatibility testing.
- Develop and execute device and cell product compatibility studies to evaluate the impact of device materials, operating conditions, and delivery parameters on cell quality, viability, and dose accuracy.
- Develop and execute device qualification and validation strategies to ensure device performance, reliability, safety, and compatibility under intended clinical-use conditions. Collaborate with Regulatory Affairs to support device regulatory strategies and preparation of 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 quality and regulatory requirements.
- Support device-related change controls, technical assessments, investigations, and continuous improvement activities.
- Support device design transfer, manufacturing readiness, and lifecycle management activities in preparation for commercialization.
- Prepare and review technical documentation, including protocols, reports, specifications, procedures, risk assessments, and regulatory submission materials.
- Support clinical device implementation in coordination with the Cell Delivery team, including device configuration, readiness, technical troubleshooting, complaint investigations, and collection of device performance and usability feedback. Present project updates, technical assessments, and development progress to cross-functional teams and management.
- Proactively identify technical, quality, and regulatory risks and develop mitigation strategies to ensure successful execution of device development activities.
- Demonstrate strong ownership, accountability, and follow-through to ensure timely completion of responsibilities and project deliverables.
Qualifications
- Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, Bioengineering, or a related engineering or scientific discipline.
- Minimum of 7 years of relevant experience in medical device development, biotechnology, pharmaceuticals, or related regulated industries.
- Demonstrated experience managing medical device development projects, including coordination of cross-functional teams, external manufacturers, and project deliverables.
- Strong knowledge and hands-on experience with medical device design controls, Design History Files (DHF), device verification and validation, and risk management.
- Experience working within regulated device and combination product quality systems, including knowledge of the 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 regulatory requirements for medical devices and combination products, including experience supporting regulatory submissions and device regulatory strategies.
- Experience with human factors engineering, usability evaluations, and use-related risk management.
- Demonstrated ability to independently manage complex projects, prioritize competing activities, and drive deliverables within established timelines.
- Strong technical writing, organizational, communication, and presentation skills, with the ability to communicate complex technical information to cross-functional teams and management.
- Experience working with original equipment manufacturers (OEMs), contract manufacturers, and external device development partners preferred.
- Experience with drug-device or biologic-device combination products preferred.
- Experience with infusion pumps, syringe-based delivery systems, surgical devices, or other drug delivery technologies preferred.
- Experience developing or qualifying devices for cell or gene therapy preparation and delivery, with an understanding of clinical workflows and product quality considerations, preferred.
- Experience supporting medical device development from clinical-stage use through commercial launch preferred.
- Knowledge of FDA 21 CFR Part 4, EU MDR, ISO 62366-1, and applicable international combination product regulatory requirements preferred.
- Experience preparing device-related CMC documentation and supporting combination product regulatory submissions, including BLAs and marketing authorization applications, strongly preferred.
- Exceptional organizational and time management skills, with the ability to work effectively in a fast-paced, dynamic environment.
- Self-motivated with strong initiative, problem-solving skills, and a demonstrated ability to work independently and collaboratively.