Job at a glance
Description WARNING about fake job posting scams. There has been a recent wave of scams whereby third parties post fake job openings using a bogus email address that resembles [email protected] . Under the guise of asking you to fill out an application, the scammers are attempting to gather your personal information. See the Federal Trade Commission’s warning on this topic at: https://consumer.ftc.gov/articles/job-scams The only official source for actual Biolinq job postings/openings is at www.biolinq.com/careers .
While other job sites (such as LinkedIn, Indeed or Glassdoor) may pull from Biolinq’s careers web page, you should visit www.biolinq.com/careers to verify the accuracy of the openings found on third party web sites. 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. In the initial phase, the Supervisor will help install, qualify, and validate pilot line equipment and processes. As the company scales toward commercial volumes, the role will evolve into ongoing supervision of a growing, multi-shift production team, and will expand in scope as new product lines are introduced.
Location will be Biolinq's corporate headquarters in San Diego CA. Duties and Responsibilities: Pilot Line Build and Start-Up 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. Ongoing Line Supervision 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; escalate 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. Quality, Compliance and Safety 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 relat