Manufacturing Supervisor

Manufacturing Supervisor (Pilot Line)

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 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.

Continuous Improvement and Scaling

• 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.

Requirements

• 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 experience is a plus.
• Comfortable operating with ambiguity and building structure where little currently exists. This role will help define the processes it later runs.
• Strong troubleshooting and hands-on problem-solving skills in an equipment- and process-driven environment.
• Working knowledge of lean manufacturing and continuous improvement methods (5S, root cause analysis).

Preferred Skills: Soft Skills, Collaboration and Values

• Kindness – Treats current staff, technicians, new operators and cross-functional partners with patience and respect, especially when troubleshooting under pressure.
• Innovation – Brings creativity and resourcefulness to first of their kind problems that don't yet have a guide or instructions.
• Trust – Communicates transparently, follows through reliably, and gives team, colleagues, and leadership confidence in their work and word.
• Excellence – Is detailed and accurate in documentation and execution, works to minimize errors, and does more than the minimum required, taking real pride and ownership in the product and the team's work.
• A natural collaborator and team player who works effectively across Engineering, Quality, Supply Chain, and Operations Leadership.
• Strong coaching and people-leadership instincts, including scheduling and performance management across a growing, multi-shift team.
• Ability to build something new and scale it responsibly, balancing speed with the rigor a medical device requires.

Working Conditions

• Primary work setting is a manufacturing cleanroom/controlled lab environment, requiring compliance with gowning and other cleanroom entry and behavior protocols.
• Extended periods of standing and walking on the production floor; frequent bending, reaching, and fine motor movement while working with small components, sensors, and equipment.
• Ability to lift and carry up to 25 pounds (e.g., materials, fixtures, supplies).
• Exposure to typical cleanroom/lab conditions, including controlled temperature and humidity, and use of required personal protective equipment (PPE) such as lab coats, gloves, masks, hairnets, and safety glasses.
• May involve close visual work and use of microscopes, magnification tools, or precision instrumentation.
• Willingness to work flexible hours, including off-shift or weekend coverage, particularly during line build-out, validation, and scale-up phases.

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to handle or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk, or hear in a standard office environment, Employee may occasionally lift/or move up to 50 pounds.

Benefits

Medical, dental, vision, health savings account, flexible spending account, life and long-term disability insurance, 401(k) plan, holidays, and PTO.