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About the Role

Neurona Therapeutics is seeking a self-motivated and detail-oriented Process Engineer / Senior Process Engineer to support device development for their cell therapy combination product program. The role involves evaluating, selecting, developing, qualifying, and commercializing devices and delivery systems for cellular therapeutics, requiring strong engineering and testing skills in a cross-functional environment.

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.
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.
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.
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.
Analyze and interpret experimental data, summarize conclusions, and present evidence-based recommendations to cross-functional teams and management.

Requirements

Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, Bioengineering, Chemical Engineering, or a related engineering or scientific discipline.
Minimum of 3 years of relevant industry 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.
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.
Strong technical writing, communication, and presentation skills.
Exceptional organizational and project management skills, with the ability to manage multiple priorities and take ownership of projects.
Self-motivated, adaptable, collaborative, and comfortable working in a fast-paced environment.

Skills

Cell therapy products
Cell suspensions
Biologics
Drug delivery systems
Infusion systems
Syringes
Tubing sets
Pumps
Catheters
Administration devices
Device development principles
Design controls
Requirements development
Risk management
Verification
Validation
Traceability
Design transfer
Change control
Device qualification
Process characterization
Process validation
Commercialization
Lifecycle management
Technical writing
Communication
Presentation skills
Organizational skills
Project management
External device manufacturers
Suppliers
Test laboratories
Development partners
Applicable medical device and combination product regulations
Quality system requirements
Consensus standards
Aseptic processing
GMP
Product-device compatibility
Dose delivery accuracy
Material compatibility
Extractables and leachables
Biocompatibility
Sterilization
Packaging
Shipping
Human factors

Location

SOUTH SAN FRANCISCO, CA, 94080

Work Type

Full Time
On-Site

Experience Level

Senior

Education Level

Bachelor’s degree
Master’s degree

About the Company

Neurona Therapeutics is a clinical-stage biotechnology company based in South San Francisco focused on the development of cell-based therapies for neurological diseases.