Manufacturing Supervisor

Biolinq Incorporated • San Diego, CA

20d • $85,000 - $101,000 • Onsite

About The Position

Biolinq is seeking a Manufacturing Supervisor to establish and lead their first pilot manufacturing line. This role is crucial for translating lab-scale processes into a repeatable, compliant, and scalable production line. Initially, the supervisor will assist with equipment installation, qualification, and validation. As the company grows, the role will expand to include daily supervision of a multi-shift production team and new product lines. The position is based at Biolinq's headquarters in San Diego, CA.

Requirements

• B.S. degree or higher in Operations Management, Engineering, 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 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.
• 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).

Nice To Haves

• 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.

Responsibilities

• 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.
• Translate process development and engineering documentation into standard operating procedures (SOPs) and work instructions.
• Identify and troubleshoot process, equipment, and workflow issues in partnership with Engineering and Quality.
• Contribute to line layout, material flow, and staffing plans for pilot-scale output and future scale-up.
• Supervise day-to-day pilot line operations, including staffing, scheduling, and coverage across shifts.
• Directly supervise, coach, and develop manufacturing associates and line technicians; conduct performance reviews and support hiring and onboarding.
• Monitor production schedules, throughput, and yield; escalate and drive resolution of issues.
• 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.
• Manage inventory control and transactions in the ERP system.
• Cover the commercial line when needed.
• Perform other duties as required to support team 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.
• 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.
• Help build training programs, documentation, and team structures for future product lines.

Benefits

• Medical, dental, vision, health savings account, flexible spending account, life and long-term disability insurance, 401(k) plan, holidays, and PTO.
• Annual performance bonus and/or other applicable incentive compensation plans.
• Paid time off (vacation, holidays, sick time, parental leave).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level