Director of Medical Operations

About the role

Eight Sleep is on a mission to revolutionize sleep through advanced technology, and we are currently enhancing our Pod platform to integrate medical diagnostics and therapeutic solutions. We are looking for a Director of Medical Operations who will spearhead the manufacturing and operational strategies for our medical products division, ensuring that we deliver high-quality solutions that meet regulatory standards and consumer needs.

Key facts

What you'll do

• Develop and implement robust manufacturing controls to ensure operational efficiency while maintaining rapid production timelines.
• Collaborate closely with Research & Development, Clinical Affairs, and Quality Assurance/Regulatory Affairs teams to design and execute comprehensive testing programs for our medical products.
• Lead cross-functional engineering teams in the preparation and management of risk management documentation to ensure compliance with industry standards.
• Coordinate with consumer operations leaders to accelerate the deployment of upgrades and enhancements to our medical product offerings.
• Analyze the financial implications of adapting medical products for entry into new markets, ensuring strategic alignment with business goals.
• Oversee the entire lifecycle of medical product development, from concept through to market launch, ensuring adherence to timelines and budgets.
• Foster a culture of continuous improvement within the manufacturing process, identifying areas for optimization and implementing best practices.
• Ensure that all operations comply with FDA regulations and other relevant health and safety standards, maintaining a focus on quality and patient safety.
• Mentor and develop team members, providing guidance and support to enhance their professional growth and operational effectiveness.
• Prepare and present operational reports to senior management, highlighting key performance indicators and strategic recommendations.
• Engage with external stakeholders, including regulatory bodies and industry partners, to stay informed about trends and changes in the medical device landscape.
• Drive initiatives to enhance customer satisfaction and product usability, ensuring that our medical products meet the needs of users effectively.

Requirements

• At least 8 years of professional experience in manufacturing or operations specifically within the medical device industry.
• A successful track record of obtaining FDA clearances, particularly through the 510(k) or De Novo pathways.
• Proven experience in managing cross-functional programs and projects, demonstrating strong leadership capabilities.
• Familiarity with launching and managing global manufacturing initiatives, with an emphasis on scalability and efficiency.
• A Bachelor's degree or equivalent professional experience in a relevant field.
• Strong analytical skills, with the ability to evaluate complex data and make informed decisions.
• Excellent communication and interpersonal skills, capable of working collaboratively across diverse teams.
• A proactive approach to problem-solving, with a focus on innovation and continuous improvement.

Nice to have

• Advanced degree in a related field, such as an MBA or Master's in Engineering.
• Experience with digital health technologies or sleep-related products.
• Knowledge of international regulatory requirements for medical devices.
• Familiarity with lean manufacturing principles and methodologies.
• Previous experience in a startup environment, demonstrating adaptability and resilience.

Skills & tools

• Proficient in project management software and tools to track progress and manage timelines effectively.
• Strong understanding of quality management systems and regulatory compliance frameworks.
• Familiarity with data analysis tools and methodologies to assess operational performance.
• Ability to utilize communication platforms for effective team collaboration and stakeholder engagement.

Practical notes

• This role operates in a fast-paced environment, with expectations for team members to work over 60 hours per week when necessary.
• Employees enjoy a range of benefits, including access to a company Pod, comprehensive health, vision, and dental insurance for themselves and their dependents, as well as supplemental life insurance.
• Flexible paid time off (PTO) policies, commuter benefits, and paid parental leave are also part of the benefits package.
• All full-time staff members are eligible for equity participation, with opportunities for performance-based equity refreshers.
• Eight Sleep is committed to fostering an inclusive workplace and is proud to be an equal opportunity employer.