VP of Operations (Manufacturing)

Kandu•Van Nuys, CA

3d•$230,000 - $250,000

About The Position

In April 2025, Kandu Health and Neurolutions merged to form Kandu Inc. to pioneer an integrated approach to stroke recovery, combining FDA-cleared brain-computer interface technology with personalized telehealth services. The company’s IpsiHand® device is durable medical equipment that enables chronic stroke survivors to regain upper extremity function in daily home use. Combining this advanced technology with the support of expert clinicians offers a comprehensive path to recovery– helping survivors improve mobility, independence, and quality of life. Kandu extends recovery beyond the hospital through principal illness navigation, providing one-on-one education, care coordination, and advocacy; grounded in clinical evidence and informed by the lived experiences of patients and their families. The Vice President of Operations at Kandu will lead the development and execution of a comprehensive operations strategy, spanning from production planning and resource allocation to end-to-end operational workflows.

Requirements

15+ years of operations leadership experience in the medical device industry, including direct oversight of manufacturing, supply chain, logistics, and field operations (scaled from Director requirement).
7+ years of experience leading operations and manufacturing teams in a fast-paced environment (scaled from Director requirement).
Deep knowledge of medical device operations, manufacturing processes, DME requirements, regulations, and quality systems.
Experience developing operations strategies, KPIs, performance frameworks, and scaling device servicing or fleet management models.
Superb organizational and planning skills, adept at managing multiple operational priorities and tight deadlines.
Exceptional communication and interpersonal skills, fostering collaboration across engineering, regulatory, quality, commercial, and operations teams.
A meticulous eye for detail and a commitment to producing the highest quality devices while running efficient and compliant operations.
Experience with fleet management, logistics, and service of active medical devices is required.

Responsibilities

Operations Strategy & Production Planning: Develop and own the overall operations strategy, including production planning, manufacturing capacity, resource allocation, and operational workflows. Create detailed plans to ensure efficiency, quality, and scalability while satisfying market demand and supporting commercial growth.
End-to-End Operations Management: Lead day-to-day operations across manufacturing, supply chain, field operations, logistics, and device servicing. Ensure operational readiness, consistent execution, and alignment with business objectives.
In-House Manufacturing Oversight: Oversee the setup, optimization, and ongoing management of the manufacturing facility to meet strict medical device standards. Manage the assembly, testing, and release of medical devices to the highest quality standards, ensuring supply satisfies demand within an integrated operations framework.
Supply Chain & CM Management: Manage contract manufacturers (CMs), suppliers, and logistics partners to ensure quality, competitive terms, and on-time delivery of components and finished goods. Establish operational standards for sourcing, supplier performance management, materials flow, and continuity planning.
Fleet Management System: Establish and run a world-class fleet management system—including repair operations, logistics, reverse logistics, field support, and tracking of company-owned devices—to support the commercialization and service of the IpsiHand System.
Durable Medical Equipment (DME) Operations: Translate DME regulatory requirements into operational standards across device provisioning, field operations, documentation, and service workflows. Ensure compliance with DME regulations while delivering operational efficiency and consistent customer experience.
New Product Introduction (NPI): Lead the seamless transfer of new medical devices from development to production, ensuring manufacturability, serviceability, scalability, and operational readiness. Collaborate closely with R&D to integrate operations considerations early in product development.
Regulatory Compliance: Ensure adherence to all regulatory requirements (e.g., ISO 13485, 21 CFR 820, FDA DME regulations) and industry best practices throughout the operational and manufacturing lifecycle.
Quality & Continuous Improvement: Monitor and analyze operational performance and manufacturing data, identifying and resolving issues promptly. Partner with QARA to eliminate nonconformances, implement corrective actions, and drive continuous improvement across operations.
Documentation & Control: Develop and maintain accurate and comprehensive operations and manufacturing documentation, including SOPs, work instructions, batch records, and service procedures. Implement robust document control systems to ensure traceability, compliance, and consistent execution.
Inventory & Materials Management: Oversee inventory planning, materials management, and stock levels across manufacturing and field operations to support uninterrupted production and device serviceability while minimizing waste.
Team Leadership: Lead, train, and motivate operations and production personnel on new devices, processes, and procedures in a fast-paced environment. Build a strong execution culture focused on accountability, operational discipline, and continuous improvement.