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

Canon Recruiting Group•Irvine, CA

1d•Hybrid

About The Position

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.

Requirements

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.
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.
Bachelor's in Engineering, Supply Chain, Operations, Biomedical Engineering, or related field.

Nice To Haves

Experience at or with CMs/EMS providers (Flex, Jabil, Celestica, Plexus, Sanmina) in Class II medical device or wearable programs is a strong plus.
Familiarity with the 510(k) process and manufacturing documentation (process validations, DMR/DHR) strongly preferred.
MBA or advanced degree a plus.

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.