Senior Manufacturing Manager

Biolinq Incorporated•San Diego, CA

just now•Hybrid

About The Position

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. 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.

Requirements

Bachelor's degree in Engineering, Manufacturing, Operations Management, or a related field.
Minimum of 10 years plus of progressive experience in manufacturing operations, with at least 3-5 years in a leadership role within the medical device industry.
Proven experience in a highly regulated environment (FDA/ISO 13485) is required; experience with combination products or electro-mechanical devices is a strong plus.
Experience in high-volume manufacturing scale-up and commercial launch is highly desirable. Experience in early-stage, startup, or high-growth environment is strongly preferred. Experience scaling manufacturing from pilot to higher volume preferred.
Deep knowledge of Lean Manufacturing, Six Sigma (Green or Black Belt preferred), and process validation.
Strong understanding of production planning, ERP/MRP systems (e.g., SAP, Oracle), and inventory management principles.
Demonstrated ability to lead, inspire, and develop teams through periods of rapid growth and change.
Excellent problem-solving, analytical, and decision-making skills with a hands-on, "in the trenches" leadership style.
Outstanding communication and interpersonal skills, with the ability to collaborate cross-functionally with R&D, Quality, and Commercial teams.
Demonstrated Evidence being a strong team builder with integrity, resilience, curiosity and empathy.
High ownership mindset; comfortable with ambiguity and change; strong decision-making; ability to influence without authority; calm and solution-oriented under pressure; strong communication across technical and non-technical audiences; emotional intelligence and strong people judgment; grow mindset and learning agility.
Performance management and coaching capability; conflict resolution and employee relations judgment; workforce planning and staffing strategy; change management leadership; developing first-line supervisors and future leaders; leading through rapid company growth phases; building structure without creating bureaucracy.
Medical device or regulated manufacturing environment experience. Knowledge of: GMP/QSR/ISO quality environments; process validation concepts; manufacturing documentation systems; production planning concepts; root case analysis tools; lean manufacturing principles. Experience scaling production volume.
Builds processes from scratch; comfortable wearing multiple hats; strong prioritization skills; resourceful with limited resources; balances speed with compliance; understands when to implement structure vs remain flexible.
Regulated manufacturing lifecycle; production flow and material control; capacity modeling and production scaling; workforce skill development and training systems; risk-based decision making; audit readiness and documentation discipline.

Responsibilities

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.
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.
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.
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.