Process Engineer / Sr. Process Engineer, Device Development

Neurona Therapeutics•South San Francisco, CA

1d•Onsite

About The Position

Neurona Therapeutics, a clinical-stage biotechnology company based in South San Francisco, is seeking a self-motivated and detail-oriented Process Engineer or Senior Process Engineer to support device development for its cell therapy combination product program. The role contributes to the evaluation, selection, development, qualification, and commercialization of devices and delivery systems used to prepare and administer cellular therapeutics. It requires engineering fundamentals and hands-on benchtop testing, along with the ability to plan and execute studies, convert product and user needs into device requirements, troubleshoot technical challenges, and advance device solutions in a cross-functional environment. The position works with internal functions and external partners to integrate device activities into the combination product development plan. It develops technical documentation and evidence to support clinical development, regulatory submissions, process validation, and commercialization. The job description notes that duties and responsibilities may change or be supplemented.

Requirements

Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, Bioengineering, Chemical Engineering, or a related engineering or scientific discipline.
At least 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.
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.
Experience developing technical protocols, reports, specifications, SOPs, risk assessments, and engineering documentation suitable for a regulated environment.
Strong analytical and problem-solving skills, including applying engineering principles, structured root-cause analysis, and risk-based decision-making.
Strong technical writing, communication, and presentation skills, including the ability to communicate study results, risks, and recommendations to technical and nontechnical stakeholders.
Organizational and project management skills, with the ability to manage multiple priorities and own 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.

Nice To Haves

Experience with cell therapy products, cell suspensions, biologics, drug delivery systems, infusion systems, syringes, tubing sets, pumps, catheters, or other administration devices.
Experience working with external device manufacturers, suppliers, test laboratories, or development partners.
Familiarity with applicable medical device and combination product regulations, quality system requirements, and consensus standards.
Familiarity with aseptic processing, GMP, and the operational needs of clinical-stage products.
Understanding of product-device compatibility, dose delivery accuracy, material compatibility, extractables and leachables, biocompatibility, sterilization, packaging, shipping, or human factors.

Responsibilities

Lead or support evaluation, selection, development, and implementation of devices and delivery systems for the 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.
Design, plan, and execute benchtop studies to evaluate and optimize device performance, reliability, reproducibility, usability, and cell preparation and delivery processes, including compatibility with cell therapy products and administration workflows.
Assess how device materials, fluid paths, hold times, flow conditions, delivery parameters, and operating conditions affect 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, as applicable.
Perform and document device- and process-related risk assessments, including failure mode analyses, and define appropriate risk controls and mitigation strategies.
Investigate and troubleshoot device and delivery-process issues; conduct root-cause analyses and support corrective and preventive actions, change controls, and continuous improvement.
Evaluate device manufacturers, suppliers, components, materials, and emerging technologies; support supplier qualification, device lifecycle management, and development of 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 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; 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.