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  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.

• 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.

• 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%.

• 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…