Head of Operations and Production

Exero Medical is a breakthrough medical device company developing the xBar System, a clinical decision support system intended to save lives and reduce healthcare costs. The xBar System is a combination hardware and software medical device designed to integrate seamlessly into clinical workflows, supporting procedural execution and decision making while maintaining a high standard of safety, reliability, and usability.

Position Summary

The Head of Operations and Production will be responsible for building and leading Exero Medical’s manufacturing and operations capabilities from early stage production through scale up. This role requires a strong understanding of medical devices that combine hardware and software, including the implications for manufacturing, configuration control, traceability, and release.

The position is highly hands on and requires close collaboration with engineering, quality, and regulatory teams to ensure robust design transfer, controlled manufacturing processes, and production readiness. The Operations and Production Lead will play a key role in translating engineering requirements into manufacturable, scalable, and compliant production systems, supporting both small scale builds and transition to mass production.

Key Responsibilities

Manufacturing and Production

·      Lead production of the xBar System during pilot, early commercial release, and scale up.

·      Establish and document manufacturing processes,

·      Define production capacity, line layout, tooling, fixtures, and equipment needs.

·      Oversee day to day manufacturing activities,

·      Support labeling, packaging, and device release activities

Engineering Transfer and Collaboration

·      Work closely with R&D to understand product design, software configuration, and critical system requirements

·      Lead design transfer from engineering to manufacturing, including hardware, software, and system level considerations

·      Identify design for manufacturability and design for assembly improvements and drive implementation

·      Support verification, validation, and production readiness activities

·      Ensure controlled transfer of software components, including field deployment

Quality and Regulatory Alignment

·      Ensure manufacturing processes comply with FDA QSR and ISO 13485 requirements

·      Support process validation, including IQ, OQ, and PQ as required

·      Partner with Quality to manage nonconformances, CAPAs, and change control related to production

·      Maintain traceability, device history records, and manufacturing documentation,

Supply Chain and Logistics

·      Build and manage supplier relationships for mechanical, electronic, and software related components

·      Support supplier qualification, onboarding, and performance monitoring

·      Manage inventory, purchasing, and logistics to support production and clinical or commercial needs

·      Coordinate inbound materials and outbound shipments in compliance with regulatory requirements

Scale Up and Mass Production

·      Develop and execute the transition plan from low volume production to mass manufacturing

·      Support selection and transfer to contract manufacturers as needed

·      Define cost of goods targets based on commercialization requirements and drive continuous improvement to reduce cost and increase yield

·      Establish KPIs for manufacturing performance, quality, and delivery

Qualifications and Experience

·      Bachelor’s degree in engineering, operations, manufacturing, or a related technical field

·      7 plus years of experience in medical device manufacturing or operations

·      Proven experience with combination hardware and software medical devices

·      Proven experience with mechanical engineering and/or medical product design

·      Experience transferring products from R&D into regulated production environments

·      Strong understanding of FDA and ISO manufacturing requirements

·      Experience working in small or early stage companies is strongly preferred

Key Skills and Attributes

·      Strong technical understanding of mechanical, electronic, and software integrated systems

·      Highly organized with attention to detail and documentation

·      Comfortable wearing multiple hats in a fast paced startup environment

·      Excellent cross functional communication and leadership skills

• Practical problem solver with a bias toward execution