Senior Manufacturing Manager

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About the Company

Biolinq is a venture-backed digital health company developing a wearable biosensor platform that measures biomarkers important to the management of many clinical conditions including diabetes. This dynamic role is a part of a team of engineers and scientists developing a novel intradermal biosensor technology and the associated software data extraction and rendering SDK that will transform the way people manage their metabolic health.

Job Purpose:

This role is responsible for leading daily manufacturing operations while building scalable processes, systems, and team capability to support future commercial growth. Ensures safe, compliant, and high-quality, and cost-effective production. Operates in a highly dynamic startup environment and must balance hands‑on operational execution with strategic infrastructure development to support transition from development / early production into commercial manufacturing scale. Leads people, builds processes, and is a cross‑functional partner who can establish structure without slowing innovation and can grow into broader operational leadership over time.

Duties and Responsibilities:

Manufacturing Operations & Planning

• Oversee day‑to‑day manufacturing operations, ensuring production schedules are met to satisfy commercial demand and clinical supply needs.
• Partner with Quality, Engineering, Supply Chain, and Regulatory teams.
• Own the site’s production and capacity planning, optimizing labor, equipment, and material resources to align with sales forecasts and business objectives.
• Manage the master production schedule, coordinating with supply chain and procurement to ensure material availability and mitigate supply risks.
• Establish and track key performance indicators (KPIs) for safety, quality, delivery, cost, and inventory (SQDCI), driving daily management and accountability.

Quality & Regulatory Compliance

• Ensure all manufacturing activities are performed in strict compliance with FDA 21 CFR 820, ISO 13485, and other applicable domestic and international regulatory requirements.
• Foster a "Quality First" culture, partnering closely with Quality Assurance to maintain the facility’s readiness for internal and external audits.
• Oversee the development and maintenance of manufacturing documentation, including Device History Records (DHRs), work instructions, and batch records.

Continuous Improvement & Scale‑Up

• Lead the transition of new products from development into commercial manufacturing, utilizing Design for Manufacturability (DFM) principles.
• Drive the implementation of Lean manufacturing and Six Sigma methodologies to reduce waste, optimize throughput, and improve Overall Equipment Effectiveness (OEE).
• Lead process validation activities (IQ/OQ/PQ) and champion root‑cause analysis and corrective action (CAPA) for manufacturing‑related issues.
• Implement process automation when appropriate.

Team Leadership & Development

• Hire, coach, lead, mentor, and develop a growing team of manufacturing associates, production supervisors, planners and technicians.
• Build career paths and skill matrices for manufacturing roles.
• Cultivate a culture of safety, engagement, continuous learning, accountability, and ownership, ensuring all team members are trained and empowered to solve problems at the source.
• Manage departmental budgets, headcount planning, and performance reviews to build a high‑performing operations team.

Qualifications:

• Bachelor’s degree in Engineering, Manufacturing, Operations Management, or a related…