Job Description
POSITION SUMMARY
The Head of Operations and Manufacturing will own the end-to-end operational infrastructure required to bring the client’s FDA-regulated cuffless blood pressure monitor to market and scale production to meet clinical and commercial demand. This is a hands-on leadership role for someone who thrives in building from zero to one within a regulated environment: selecting contract manufacturers with medical device experience, standing up supply chains compliant with FDA 21 CFR Part 820, establishing and maintaining ISO 13485-certified quality management systems, and preparing for physician-directed, direct-to-patient fulfillment.
As an early-stage company preparing for 510(k) submission and subsequent 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 the complexities of regulated hardware supply chains and design transfer, and can roll up their sleeves to get things done while building the team and processes needed for long-term growth. Candidates with experience at contract manufacturers or electronic manufacturing services (EMS) providers serving the Class II medical device or wearable technology industries are especially encouraged to apply.
This position reports directly to the CEO and offers high visibility with the leadership team and Board of Directors. It is an ideal opportunity for an operations leader who wants to shape the manufacturing, quality, and fulfillment strategy of a fast-growing medical technology company from the ground up.
KEY RESPONSIBILITIES
Manufacturing & Production
- Lead the selection and onboarding of contract manufacturing partners with Class II medical device experience, including RFQ process, quality system audits, due diligence, contract negotiation, and ongoing relationship management.
- Own the design transfer and manufacturing transfer process, working closely with engineering to ensure design-for-manufacturing (DFM) principles are applied, Device Master Record (DMR) requirements are met, and production readiness is achieved.
- Establish and manage production planning, forecasting, and capacity management to support Verification & Validation (V&V) builds, pilot production, and volume manufacturing.
- Drive continuous improvement in manufacturing yield, quality, and cost-efficiency while maintaining compliance with FDA and ISO requirements.
- Oversee pilot production runs and scale-up to volume manufacturing, including process validation (IQ/OQ/PQ) and manufacturing process controls.
Supply Chain & Procurement
- Build and manage the end-to-end supply chain for a regulated medical device, including component sourcing, supplier qualification, and inventory management in compliance with FDA purchasing controls.
- Develop supplier relationships and negotiate favorable terms while ensuring supply continuity, traceability, and risk mitigation.
- Implement inventory planning and management systems to balance working capital with service levels, including buffer inventory strategies critical for Year 1 launch.
- Monitor and mitigate supply chain risks, including component shortages, single-source dependencies, geopolitical factors, and logistics disruptions.
- Manage relationships with key component suppliers, including the initialization cuff development partner, ensuring readiness for software integration and pilot validation testing.
Quality & Regulatory Compliance
- Maintain and continuously improve the ISO 13485-certified Quality Management System (QMS) in partnership with the quality and regulatory team, ensuring compliance with FDA 21 CFR Part 820 (Quality System Regulation).
- Support 510(k) submission activities related to manufacturing, including process validation documentation, device master record (DMR) development, and establishment of device history records (DHR).
- Define and implement incoming inspection, in-process controls, and final product testing protocols consistent with the product’s risk management file and design verification/validation requirements.
- Manage product certifications and compliance requirements for a Class II medical device, including FDA registration and listing, UDI compliance, and applicable international regulatory requirements (CE marking/MDR, if applicable).
- Lead root cause analysis and corrective/preventive actions (CAPA) for quality issues, ensuring compliance with post-market surveillance requirements.
- Support design control activities, including traceability of design inputs, outputs, and verification/validation activities within the Greenlight Guru QMS platform.
Fulfillment & Logistics
- Design and implement the direct-to-patient fulfillment strategy, including 3PL selection with FDA-cleared Class II device experience, CAPA and returns handling for regulated devices, and warranty tracking capabilities.
- Establish logistics and distribution processes to support nationwide (and eventually international) shipping of a regulated medical device, ensuring chain-of-custody and traceability requirements are met.
- Develop returns, replacement, and warranty processes that deliver excellent patient experience while managing costs and maintaining regulatory compliance.
- Ensure a branded fulfillment experience, including 1-day shipping capability and real-time inventory visibility integrated with e-commerce and CRM systems.
Team & Organizational Development
- Start as an individual contributor who can execute hands-on, then build and lead the operations team as the company scales through 510(k) clearance and commercial launch.
- Establish operational metrics, dashboards, and reporting to provide visibility into manufacturing, supply chain, and quality system performance.
- Partner with finance on cost modeling, margin analysis, COGS optimization, and operational budgeting.
- Collaborate cross-functionally with engineering, software, regulatory, and commercial teams to ensure alignment on product development milestones and launch readiness.
TERM & START
- Part-time (10-30 hours/week)
- Start 2-3 weeks from an offer.
- Remote, located in CA or willing to relocate
- 25% travel, domestically and internationally