About NeurOptics

NeurOptics Inc. is the leader in the science of pupillometry. Driven by a passion to help clinicians improve patient outcomes, NeurOptics develops objective, data-driven technologies for critical care nursing, critical care medicine, neurology, neurosurgery, and emergency medicine. The company’s technologies help clinicians evaluate neurological function by providing objective information from the human eye to support critical medical decision-making.

Headquartered in Irvine, California, NeurOptics is represented in the United States and more than 27 countries worldwide. At NeurOptics, we are passionate patient advocates. Helping clinicians improve neurological outcomes is our life’s work.

Position Summary

The Director of Engineering will lead the engineering organization responsible for translating NeurOptics’ next-generation clinical, optical, and algorithmic concepts into robust, manufacturable, compliant medical-device products.

This role owns engineering execution from feasibility assessment and system architecture through product development, production transfer, and sustaining engineering. The position requires a strong systems-level leader who can integrate hardware, software, embedded systems, image processing, signal processing, clinical data workflows, and algorithm implementation into reliable products used in high-acuity clinical environments.

The Director of Engineering will partner closely with the CEO, CTO, VP Innovation, Chief Scientist, VP Operations, Quality/Regulatory, and cross-functional teams to ensure that engineering outputs are technically sound, clinically meaningful, manufacturable, scalable, and compliant with applicable medical-device standards.

Key Success Outcomes

• Successfully translate new product concepts into clear system architectures, engineering requirements, development plans, and risk-reduction strategies.
• Deliver robust, manufacturable, testable, and compliant designs through design controls, verification, validation, and production transfer.
• Build and lead a high-performing engineering team capable of executing across hardware, software, algorithms, imaging, signal processing, and sustaining engineering.
• Reduce technical risk early through structured feasibility assessment, prototyping, technical reviews, root-cause analysis, and cross-functional decision-making.
• Create an engineering culture that balances innovation, execution discipline, quality, clinical relevance, and regulatory rigor.

Core Responsibilities

• Own feasibility assessment and system architecture for new and existing product platforms.
• Lead engineering development from concept definition through production release and sustaining support.
• Define and maintain system-level architecture across hardware, software, embedded systems, data pipelines, image processing, signal processing, and algorithm implementation.
• Convert clinical, scientific, and innovation concepts into structured engineering requirements, specifications, architecture, development plans, and verification strategies.
• Oversee implementation of image processing, signal processing, clinical algorithms, and related software workflows in collaboration with scientific and clinical stakeholders.
• Drive execution across multiple concurrent engineering programs, balancing technical risk, timeline, quality, regulatory requirements, and resource constraints.
• Ensure engineering outputs meet applicable quality, regulatory, safety, reliability, cybersecurity, usability, and manufacturability requirements.
• Serve as the primary escalation point for technical risks, design trade-offs, implementation decisions, and engineering execution barriers.
• Lead design reviews, architecture reviews, root-cause investigations, risk assessments, and corrective engineering actions.
• Coordinate internal engineering teams, external development partners, consultants, suppliers, and manufacturing partners to achieve project objectives.
• Mentor engineering staff and help develop the technical depth, execution discipline, and accountability of the engineering organization.
• Provide hands-on technical leadership when needed, while maintaining ownership of system-level execution and cross-functional alignment.

Required Qualifications

• Bachelor’s degree in Electrical Engineering, Computer Engineering, Biomedical Engineering, Computer Science, Systems Engineering, or a related technical field.
• Significant experience leading system-level engineering and product development for complex hardware/software products.
• Demonstrated experience taking products from concept, feasibility, and architecture through development, verification, production transfer, and sustaining support.
• Experience leading cross-functional engineering teams and managing multiple concurrent development programs.
• Strong systems-level engineering capability across hardware, software, embedded systems, algorithms, and data workflows.
• Ability to translate complex scientific, clinical, and product concepts into structured engineering solutions.
• Strong problem-solving, root-cause analysis, design review, and technical risk-management skills.
• Excellent written and verbal communication skills, with the ability to communicate effectively with executives, scientists, clinicians, engineers, operations, quality, regulatory, and external partners.
• Ability to operate effectively with autonomy, ambiguity, urgency, and accountability in a fast-paced medical-device environment.

Preferred Qualifications

• Advanced degree in engineering, computer science, biomedical engineering, optics, imaging, signal processing, or a related field.
• Experience in medical-device development under FDA design controls and ISO 13485 quality systems.
• Working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601-1, IEC 62304, and related medical-device standards.
• Experience with optical sensing, imaging systems, physiological monitoring, neurocritical care technologies, or other clinically oriented measurement systems.
• Experience with image processing, signal processing, machine learning implementation, clinical algorithms, or algorithm deployment into regulated products.
• Knowledge of machine learning, deep learning, LLM-enabled development workflows, and algorithm development would be highly desirable, particularly where these tools support clinical data analysis, product intelligence, engineering productivity, or regulated algorithm implementation.
• Experience working with contract manufacturers, external engineering partners, component suppliers, and manufacturing transfer teams.
• Experience building engineering processes, technical documentation systems, design review discipline, and scalable engineering-team structure.

Equal Employment Opportunity Statement

NeurOptics is an equal opportunity employer. Employment decisions are based on qualifications, merit, business needs, and applicable law.

Job Type: Full-time

Pay: $175,000.00 - $250,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Application Question(s):

• Do you have experience in medical device development?
• Do you have experience leading cross-functional engineering teams?

Education:

• Bachelor's (Required)

Work Location: In person