VP, Manufacturing (Medical Device)

Job Description Job Description About General Fluidics At General Fluidics, we are transforming global healthcare by making high-quality blood diagnostics radically more accessible. Our Axess™ point-of-care platform brings the analytical performance of the central lab to the bedside, enabling clinicians to make faster, more informed decisions while improving patient outcomes. Our mission is bold: to revolutionize diagnostics by delivering the most comprehensive , highest quality , and lowest cost blood testing solution to point-of-care settings. We believe the future of healthcare must be faster, more flexible, and more equitable and we’re building the tools to make that future real. Position Summary Reporting to the Chief Executive Officer, we are seeking an experienced and strategic Vice President, Manufacturing to build and lead our manufacturing function from the ground up as we target a product launch within the next 24 months. As the first dedicated manufacturing executive at General Fluidics, you will play a critical role in scaling our Axess™ diagnostic platform from early stage development into commercial production under our supply agreement with the largest animal health company in the world. This is a unique opportunity to shape the manufacturing organization of a category-defining med tech company from day one. You will be responsible for defining, building, and overseeing all aspects of manufacturing operations including design transfer, process development, supply chain integration, and contract manufacturing strategy while ensuring compliance with FDA, ISO 13485, and other regulatory standards. The ideal candidate is an execution-focused leader with deep experience in medical device manufacturing and a track record of scaling production systems for complex diagnostic technologies. Key Responsibilities Strategic Leadership & Organizational Build Develop and execute the overall manufacturing strategy aligned with product commercialization timelines and corporate growth objectives. Build and lead a world-class manufacturing organization, including team structure, hiring plans, facilities, systems, and operational processes. Establish scalable infrastructure to support both early production and high-volume commercial manufacturing. Manufacturing Operations Lead all manufacturing activities for the Axess™ system, including consumables and instrument hardware. Oversee production planning, inventory management, procurement, and materials flow to ensure efficient operations and on-time delivery. Drive continuous improvement across cost, quality, yield, and throughput. Design Transfer & Scale-Up Collaborate cross-functionally with Engineering and Research teams to ensure successful design transfer of both hardware and consumables into manufacturing. Implement scalable, validated processes for assembling and testing complex diagnostic devices and consumables. Guide pilot manufacturing activities and transition to commercial-scale production. Quality & Regulatory Compliance Ensure that manufacturing operations adhere to all applicable standards, including FDA QSR, ISO 13485, cGMP, and other global regulatory requirements. Supplier & Contract Manufacturing Management Develop the strategy for outsourced manufacturing vs. internal production; oversee management of contract manufacturing organizations (CMOs). Build strong partnerships with critical suppliers and CMOs to ensure quality, cost, and delivery performance. Establish and maintain supply agreements, technical documentation, and performance metrics. Cost Optimization & Operational Efficiency Drive cost reduction initiatives across labor, materials, and process efficiency while maintaining quality standards. Implement Lean Manufacturing, Six Sigma, and other continuous improvement methodologies to optimize operations. Qualifications Required: Bachelor’s degree in Engineering, Operations, or a related technical field; Master’s or MBA preferred. 15 years of progressive experience in manufacturing operations, with at least 8 years in medical device or diagnostic product manufacturing. Proven track record in building and scaling manufacturing operations for complex med device systems and consumables. Strong understanding of FDA regulations, ISO 13485, GMP, and international quality standards. Demonstrated experience with design transfer, process validation, and launching new products into production. Leadership experience in managing teams, facilities, vendors, and contract manufacturers. Hands-on operational leader with the ability to operate at both strategic and tactical levels. Preferred: Experience in point-of-care diagnostics or blood testing platforms. Expertise in scaling hardware consumables/products. Familiarity with automation and flexible manufacturing systems. Who You Are A builder and a doer - comfortable designing systems from scratch and scaling them as the company grows. A collaborative, low-ego leader who thrives in a mission-driven startup environment. Obsessively quality-focused, operationally savvy, and financially astute. Committed to transforming healthcare and driven by outcomes that improve lives. Company Description General Fluidics, is a clinical diagnostics company with a novel point-of-care instrument for simultaneous measurement of clinical chemistry, hematology and immunoassays from human and animal blood (https://www.generalfluidics.com). We are creating an entirely new category of blood testing technology that brings the quality and menu of the reference laboratory to the point of care. Our AxessTM diagnostic platform seamlessly integrates three “gold standard” analytical technologies to provide full hematology, clinical chemistry and immunoassay test menus. Company Description General Fluidics, is a clinical diagnostics company with a novel point-of-care instrument for simultaneous measurement of clinical chemistry, hematology and immunoassays from human and animal blood (https://www.generalfluidics.com). We are creating an entirely new category of blood testing technology that brings the quality and menu of the reference laboratory to the point of care. Our AxessTM diagnostic platform seamlessly integrates three “gold standard” analytical technologies to provide full hematology, clinical chemistry and immunoassay test menus.

Location: Watertown, Massachusetts, US

Posted Date: 8/2/2025