Vice President, Manufacturing

Company & Job Overview:

Diality is a medical device company focused on developing solutions to improve lives impacted by kidney disease. Diality offers the Moda-flx Hemodialysis System, a user-friendly, mobile, and connected hemodialysis system designed to maximize clinical flexibility and ease-of-use for both clinical and non-clinical users. The Moda-flx Hemodialysis system combines flow rate capabilities of conventional in-center dialysis devices with a fully integrated reverse osmosis (RO) water filtration system to provide a broad range of prescriptions and meet the needs of any professional dialysis care setting.

The Vice President of Manufacturing is a strategic executive responsible for leading the end-to-end operational strategy, including manufacturing, supply chain, procurement, and logistics. The ideal candidate will scale our production capabilities, optimize global supply chain resilience, and ensure uncompromising compliance with FDA, ISO 13485, and GMP regulations. This leader will bridge the gap between R&D, product development, and commercialization to deliver high-quality, cost-effective medical devices to the market

The ideal candidate will have a proven track record in Operations leadership, particularly in a medical device, medical technology or biotechnology organization. They will possess deep expertise in talent management, organizational development, and workforce planning.

This position is an office-based position at the company’s Irvine, CA headquarters.

Responsibilities:

Strategic Leadership & Execution

• Translate corporate vision into actionable operational strategies, setting short- and long-term objectives for scaling manufacturing and supply chain.

• Oversee Profit & Loss (P&L) for the operations division, managing budgets, and identifying areas for continuous cost optimization.

• Serve as a core member of the executive leadership team, collaborating cross-functionally with R&D, Quality, Regulatory, and Commercial teams.

Manufacturing & Supply Chain Management

• Direct all manufacturing operations (internal facilities and/or outsourced/CMO partnerships), ensuring production schedules are met with the highest standards of safety and quality.

• Oversee global supply chain, procurement, and logistics, mitigating risks related to material shortages and distribution delays.

• Implement Lean Manufacturing and Six Sigma methodologies to eliminate waste, reduce lead times, and improve manufacturing efficiency.

Quality Assurance & Regulatory Compliance

• Partner closely with Quality/Regulatory to uphold and enforce compliance with FDA 21 CFR Part 820, ISO 13485, and other global regulatory requirements.

• Maintain a culture of compliance and continuous improvement, proactively addressing audits, CAPAs (Corrective and Preventive Actions), and non-conformances.

• Guarantee that all products are manufactured, tested, and released according to defined specifications.

New Product Introduction (NPI) & Scaling

• Partner closely with R&D during the design transfer phase to ensure new products are manufacturable, cost-effective, and ready for commercial scale.

• Manage capacity planning, facility expansions, and capital expenditure (CapEx) projects to support product pipeline growth.

• Build, mentor, and develop a high-performing operations team, fostering a culture of accountability, innovation, and operational excellence.