Manufacturing Supervisor

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.

The MANUFACTURING SUPERVISOR (PILOT LINE) role is a newly created, foundational role responsible for standing up and then leading our first pilot manufacturing line for our product. This role will partner closely with Process Development, Quality, and Operations Engineering to translate lab-scale and engineering processes into a repeatable, compliant, and scalable production line and then take ownership of daily supervision of that line once it is operational.

Location will be Biolinq's corporate headquarters in San Diego CA.

• Partner with Process/Manufacturing Engineering to install, set up, and commission pilot line equipment and workstations.
• Support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for new equipment and processes.
• Help translate process development and engineering documentation into standard operating procedures (SOPs) and work instructions for a production environment.
• Identify and troubleshoot early-stage process, equipment, and workflow issues in partnership with Engineering and Quality.
• Contribute to line layout, material flow, and staffing plans that support both pilot-scale output and future scale-up.

• Supervise day-to-day pilot line operations, including staffing, scheduling, and coverage across shifts as the line scales.
• Directly supervise, coach, and develop manufacturing associates and line technicians; conduct performance reviews and support hiring and onboarding as the team grows.
• Monitor production schedules, throughput, and yield; elevate and drive resolution of issues that put output, quality, or timelines at risk.
• Ensure work is performed in accordance with approved SOPs, batch records/device history records (DHRs), and current Good Manufacturing Practice (cGMP) requirements.
• Lead daily tier meetings, shift hand-offs, and cross-functional communication to keep the line running smoothly.
• Manage inventory control and transaction in ERP system.
• Cover the commercial line when needed.
• Perform other duties as required to support the team’s objectives and department goals.

• Ensure manufacturing activities comply with FDA Quality System Regulation (21 CFR Part 820), ISO 13485,and other applicable medical device regulations.
• Support investigations, nonconformance reports (NCRs), corrective and preventive actions (CAPAs), and deviation handling related to the pilot line.
• Champion a strong safety culture; ensure adherence to EHS requirements and maintain a clean, organized, audit-ready work environment.
• Participate in internal and external audits and regulatory inspections as a subject matter expert on pilot line operations.

• Identify and lead continuous improvement initiatives (e.g., lean manufacturing, 5S) to improve safety, quality, throughput, and cost.
• Partner with Engineering and Operations leadership to plan the transition from pilot-scale to higher-volume production, including equipment, staffing, and process changes.
• Help build the training programs, documentation, and team structures needed to support future product lines beyond the initial CGM sensor.

• B.S. degree or higher in Operations Management, Engineer, Life Sciences, or a related field preferred; equipment hands-on experience will be considered.
• 5+ years of experience in medical device, pharmaceutical, or other regulated manufacturing environments is preferred.
• Candidates with fewer years in a formal supervisory title will also be considered if they have served as a process/technical lead, informal team lead, or subject matter expert, provided they can demonstrate the ability to stand up a new pilot line from ground up.
• Direct experience supporting new product introduction (NPI), process validation (IQ/OQ/PQ), or pilot-to-production scale-up is strongly preferred.
• Working knowledge of FDA QSR (21 CFR Part 820) and ISO 13485 requirements; direct audit…