Process Engineer​/Sr. Process Engineer, Device Development

We are hiring! Our ideal candidates are self-motivated individuals who have clearly demonstrated a passion for scientific research. This is a fantastic opportunity to join a small team, work on transformative science, and build an exciting, science-driven company. Neurona is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

Position:Process Engineer / Sr. Process Engineer, Device Development

Location: South San Francisco, CA

Job :383

# of Openings:1

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 a self-motivated and detail-oriented Process Engineer / Senior Process Engineer to support device development for Neurona’s cell therapy combination product program. The successful candidate will contribute to the evaluation, selection, development, qualification, and commercialization of devices and delivery systems used to prepare and administer cellular therapeutics. This role requires a strong foundation in engineering and benchtop testing, with the ability to design and execute studies, translate product and user needs into device requirements, troubleshoot technical challenges, and advance device solutions in a cross-functional environment.

• Lead or support the evaluation, selection, development, and implementation of devices and delivery systems for Neurona’s cell therapy combination product program.
• Develop device evaluation and selection strategies, including technical assessments, feasibility studies, comparative testing, and documented recommendations.
• Translate product, clinical, user, and commercial needs into device requirements, engineering specifications, test methods, and acceptance criteria.
• Independently design, plan, and execute benchtop studies to evaluate and optimize device performance, reliability, reproducibility, usability, and cell preparation and delivery processes, ensuring compatibility with cell therapy products and administration workflows.
• Assess the impact of device materials, fluid paths, hold times, flow conditions, delivery parameters, and operating conditions on product quality and delivered dose.
• Develop and execute device characterization, verification, qualification, and validation studies to support clinical development, regulatory submissions, process validation, and commercialization.
• Support device design controls, including user needs, design inputs and outputs, design reviews, traceability, verification and validation planning, and design transfer activities, as applicable.
• Perform and document device- and process-related risk assessments, including failure mode analyses, and define appropriate risk controls and mitigation strategies.
• Identify, investigate, and troubleshoot device and delivery-process issues; conduct root-cause analyses and support corrective and preventive actions, change controls, and continuous improvement activities.
• Evaluate device manufacturers, suppliers, components, materials, and emerging technologies, and support supplier qualification, device lifecycle management, and development of device configurations suitable for clinical use and commercialization.
• Collaborate with CMC, Manufacturing, Quality, Regulatory Affairs, Supply Chain, Clinical Operations, and external partners to integrate device activities with the overall combination product development plan.
• Develop and maintain technical documentation, including device requirements, study protocols, test methods, technical reports, SOPs, specifications, risk…