Head of Operations and Manufacturing

This role is responsible for building and leading the full operational infrastructure required to bring an FDA-regulated cuffless blood pressure monitor to market and scale production.

The position is a hands-on leadership role focused on establishing manufacturing, supply chain, and quality systems within a regulated medical device environment.

Reporting directly to the CEO, the role plays a critical part in preparing the company for 510(k) submission and commercial launch, with high visibility across leadership and the board.

Role Overview

The Head of Operations and Manufacturing will lead the development of end-to-end operations, including contract manufacturing, supply chain setup, regulatory compliance, and fulfillment strategy.

The role requires building systems from the ground up while ensuring compliance with FDA and ISO standards, and scaling production to meet clinical and commercial demand.

Responsibilities

The role includes leading the selection and management of contract manufacturing partners, overseeing design transfer, and ensuring production readiness.

It involves establishing production planning, forecasting, and capacity management, while driving improvements in manufacturing quality, yield, and cost efficiency.

The position requires building and managing the full supply chain, including supplier qualification, procurement, inventory management, and risk mitigation.

It includes maintaining and improving quality systems in compliance with ISO 13485 and FDA regulations, and supporting regulatory submissions and documentation.

The role also involves designing fulfillment and logistics processes, including direct-to-patient delivery, returns handling, and warranty management.

The position requires leading root cause analysis and corrective actions for quality issues, while ensuring compliance with post-market requirements.

It includes starting as an individual contributor and building the operations team over time, while establishing metrics, reporting systems, and cross-functional collaboration with engineering, regulatory, and commercial teams.

Qualifications

Candidates should have deep experience in medical device manufacturing, particularly within regulated environments such as Class II devices or wearable technologies.

Strong knowledge of FDA regulations, ISO 13485 quality systems, and manufacturing processes is required.

Experience with contract manufacturers, supply chain management, and production scale-up is essential.

The role requires the ability to work hands-on while building systems and teams from the ground up.

Experience in design transfer, quality systems, and regulated hardware environments is highly valuable.

Additional Information

This is a part-time role requiring approximately 10 to 30 hours per week.

The position is remote, with a preference for candidates based in California or willing to relocate.

Travel of approximately 25 percent is expected, both domestically and internationally.

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