Process Engineer / Sr. Process Engineer, Device Development

Process Engineer / Sr. Process Engineer, Device Development

Location: South San Francisco, CA, 94080

Job Type: Full Time

Work Type: On-Site

Position Overview

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.
Key Responsibilities

• 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 assessments, and qualification documentation, and support regulatory submissions and responses to health authority questions.
• Analyze and interpret experimental data, summarize conclusions, and present evidence-based recommendations to cross-functional teams and management.

Qualifications

• Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, Bioengineering, Chemical Engineering, or a related engineering or scientific discipline, with a minimum of 3 years of relevant industry experience; level will be based on experience.
• Experience in medical device, combination product, drug delivery, biotechnology, or pharmaceutical product development, including hands-on engineering or benchtop testing.
• Demonstrated experience evaluating, selecting, developing, or qualifying devices, components, disposables, or delivery systems.
• Experience with cell therapy products, cell suspensions, biologics, drug delivery systems, infusion systems, syringes, tubing sets, pumps, catheters, or other administration devices is highly desirable.
• Ability to independently design and execute experiments, develop test methods and acceptance criteria, troubleshoot technical issues, and interpret complex data.
• Working knowledge of device development principles and design controls, including requirements development, risk management, verification, validation, traceability, design transfer, and change control.
• Familiarity with device qualification, process characterization, process validation, and commercialization or lifecycle management activities.
• Experience developing technical protocols, reports, specifications, SOPs, risk assessments, and engineering documentation suitable for a regulated environment.
• Strong analytical and problem-solving skills, with experience applying engineering principles, structured root-cause analysis, and risk-based decision-making.
• Experience working with external device manufacturers, suppliers, test laboratories, or development partners is preferred.
• Familiarity with applicable medical device and combination product regulations, quality system requirements, and consensus standards is preferred.
• Familiarity with aseptic processing, GMP, and the operational needs of clinical-stage products is preferred.
• Understanding of product-device compatibility, dose delivery accuracy, material compatibility, extractables and leachables, biocompatibility, sterilization, packaging, shipping, or human factors is advantageous.
• Strong technical writing, communication, and presentation skills, with the ability to clearly communicate study results, risks, and recommendations to technical and nontechnical stakeholders.
• Exceptional organizational and project management skills, with the ability to manage multiple priorities and take ownership of projects from planning through final reporting.
• Self-motivated, adaptable, collaborative, and comfortable working in a fast-paced environment with evolving technical, clinical, and commercial requirements.

This job description is not exhaustive and not intended to cover all activities of the position. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

Alert
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