Device Manager: Cell Therapy Combination Product

Neurona Therapeutics; South San Francisco (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Neurona Therapeutics, based in South San Francisco, seeks a Device Manager to lead cell therapy device development and integration. The role encompasses design controls, risk management, and collaboration with Quality, Regulatory, and external manufacturers to ensure safe, effective combination products.

You will drive device evaluation, verification, validation, and regulatory readiness while coordinating with the Translational Medicine Cell Delivery Team to enable clinical and commercial

Qualifications

• Bachelor's or Master's in Biomedical Engineering, Mechanical Engineering, Bioengineering, or related field.
• Minimum 7 years of experience in medical device development or related regulated industries.
• Experience coordinating cross-functional teams and external manufacturers.

Responsibilities

• Manage device development projects from concept to commercialization.
• Establish design controls and DHF documentation for regulatory compliance.
• Coordinate verification, validation, and risk management per ISO 14971.
• Support regulatory submissions (INDs, BLAs) and manufacturing readiness.
• Collaborate with Cell Delivery, Quality, Regulatory, and external partners.
• Prepare technical documentation and present progress to management.

Skills

Device development

Project management

Quality systems

Regulatory affairs

Design controls

Technology evaluation

Education

Bachelor's or Master's in Biomedical Engineering / Mechanical Engineering / Bioengineering

Job description

Neurona Therapeutics, based in South San Francisco, seeks a Device Manager to lead cell therapy device development and integration. The role encompasses design controls, risk management, and collaboration with Quality, Regulatory, and external manufacturers to ensure safe, effective combination products.

You will drive device evaluation, verification, validation, and regulatory readiness while coordinating with the Translational Medicine Cell Delivery Team to enable clinical and commercial