Head of Operations and Manufacturing - Medical Device (Hybrid or Remote)

Head Of Operations And Manufacturing

The Head Of Operations And Manufacturing will own the end-to-end operational infrastructure required to bring our FDA-regulated cuffless blood pressure monitor to market and scale production. This is a hands-on leadership role for someone who thrives building from zero to one in a regulated environment: selecting contract manufacturers, standing up supply chains compliant with FDA 21 CFR Part 820, establishing ISO 13485-certified quality management systems, and preparing for direct-to-patient fulfillment.

As a company preparing for 510(k) submission and commercial launch, this role is critical to ensuring we can reliably manufacture and deliver a high-quality, FDA-cleared medical device at scale. The ideal candidate brings deep experience in medical device manufacturing (particularly wearable or electro-optical devices), understands regulated hardware supply chains and design transfer, and can roll up their sleeves while building the team and processes for long-term growth.

This position reports directly to the CEO with high visibility to the leadership team and Board of Directors.

Key Responsibilities

• Lead selection and onboarding of contract manufacturing partners with Class II medical device experience, including RFQ, quality audits, contract negotiation, and ongoing management.
• Own design transfer and manufacturing transfer, working with engineering on DFM principles, Device Master Record (DMR) requirements, and production readiness.
• Establish production planning, forecasting, and capacity management for V&V builds, pilot production, and volume manufacturing.
• Drive continuous improvement in yield, quality, and cost while maintaining FDA and ISO compliance.
• Oversee pilot runs and scale-up, including process validation (IQ/OQ/PQ) and manufacturing controls.

• Build and manage the end-to-end supply chain, including component sourcing, supplier qualification, and inventory management per FDA purchasing controls.
• Develop supplier relationships and negotiate terms while ensuring supply continuity, traceability, and risk mitigation.
• Implement inventory planning to balance working capital with service levels, including buffer strategies for Year 1 launch.
• Monitor and mitigate supply chain risks: component shortages, single-source dependencies, geopolitical factors, and logistics disruptions.

• Maintain and improve the ISO 13485-certified QMS in partnership with the quality and regulatory team, ensuring FDA 21 CFR Part 820 compliance.
• Support 510(k) submission activities related to manufacturing, including process validation documentation, DMR development, and device history records (DHR).
• Define incoming inspection, in-process controls, and final product testing consistent with the risk management file.
• Manage product certifications for a Class II device, including FDA registration, UDI compliance, and applicable international requirements.
• Lead root cause analysis and CAPA for quality issues, ensuring post-market surveillance compliance.

• Design the direct-to-patient fulfillment strategy, including 3PL selection with FDA-cleared Class II device experience.
• Establish logistics and distribution for nationwide shipping of a regulated device with chain-of-custody and traceability.
• Develop returns, replacement, and warranty processes that balance patient experience, cost, and compliance.

• Start as an individual contributor who executes hands-on, then build and lead the operations team through 510(k) clearance and commercial launch.
• Establish operational metrics and dashboards for manufacturing, supply chain, and quality performance.
• Partner with finance on cost modeling, COGS optimization, and operational budgeting.
• Collaborate cross-functionally with engineering, software, regulatory, and commercial teams.

Qualifications

• 7-12 years in manufacturing, operations, or supply chain, with 3-5+ years in medical devices (Class II preferred), wearables, or regulated hardware.
• Experience managing contract manufacturers for regulated medical devices, preferably in Asia and/or domestically.
• Experience at or with CMs/EMS providers (Flex, Jabil, Celestica, Plexus, Sanmina) in Class II medical device or wearable programs is a strong plus.
• Track record of design transfer and scaling production from pilot to volume for regulated products.
• ISO 13485 and FDA 21 CFR Part 820 experience required.
• Familiarity with the 510(k) process and manufacturing documentation (process validations, DMR/DHR) strongly preferred.
• Bachelor's in Engineering, Supply Chain, Operations, Biomedical Engineering, or related field; MBA or advanced degree a plus.
• Based in California or travel up to 25%.

Compensation

• Base Salary: $160,000 - $210,000 USD
• Performance Bonus: Tied to company milestones and personal objectives
• Equity: Early-stage stock option grant with meaningful ownership
• 100% Employer-Paid Healthcare: Medical, dental, and vision
• Additional Benefits: 401(k) with company match, flexible PTO

Working conditions may on occasion be exposed to loud sounds and distracting noise levels, such as from office equipment. The ability to lift up to 30lbs. Use of computers and technology.

At Canon Recruiting, people are our priority, and we are committed to include diversity in every segment of who we are. It is only through our diversity; we are made a stronger organization and increase our ability to provide top tier candidates that our clients have come to know Canon for. We have an inclusive environment all employees are celebrated for their unique differences. The different perspectives and experiences of our workforce give us the competitive advantage that is essential for success in an ever-changing market. By promoting inclusion with the same enthusiasm, we devote to quality and competency and using the experience from a diverse assortment of backgrounds and experiences, Canon can improve the services and value we deliver to clients, employees, and customers. At Canon, diversification and inclusiveness are much more than a corporate ambition; they are a critical component in our daily corporate life. Canon Recruiting is committed to a diverse and inclusive workplace. Canon Recruiting is an equal opportunity employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.