Pilot-Line Manufacturing Lead - Medical Devices

Biolinq Incorporated; San Diego (CA); On-site; USD 85,000 - 101,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) plan

Paid time off

Job summary

Biolinq Incorporated is building its first pilot manufacturing line for a novel intradermal biosensor platform. The role partners with Process Development, Quality, and Operations Engineering to translate lab-scale processes into a scalable production line and then supervises the line across shifts.

The candidate will support IQ/OQ/PQ activities, develop SOPs, and lead continuous improvement initiatives while ensuring FDA QSR and ISO 13485 compliant operations. San Diego HQ, on-site.

Qualifications

• Bachelor's degree or higher in a related field preferred; hands-on equipment experience valued.
• 5+ years in regulated manufacturing (medical device/pharma) preferred.
• Experience supporting NPI, IQ/OQ/PQ, or pilot-to-production scale-up is strongly preferred.
• Knowledge of FDA QSR (21 CFR Part 820) and ISO 13485; audit experience a plus.

Responsibilities

• Stand up and lead pilot manufacturing line, translate lab processes into SOPs and work instructions.
• Supervise day-to-day pilot line operations, staffing, scheduling, and multi-shift coverage.
• Ensure compliance with cGMP and batch records/DHRs; lead audits and regulatory inspections as SME.
• Identify and drive continuous improvement (lean, 5S) to improve safety, quality, throughput, and cost.
• Plan transition from pilot to higher-volume production and scale-up.
• Develop training programs and team structures for future product lines.

Skills

People leadership

Lean manufacturing

Troubleshooting

Scheduling and coaching

Cross-functional collaboration

Education

B.S. degree or higher in Operations Management/Engineering/Life Sciences

Tools

ERP system

Job description

Biolinq Incorporated is building its first pilot manufacturing line for a novel intradermal biosensor platform. The role partners with Process Development, Quality, and Operations Engineering to translate lab-scale processes into a scalable production line and then supervises the line across shifts.

The candidate will support IQ/OQ/PQ activities, develop SOPs, and lead continuous improvement initiatives while ensuring FDA QSR and ISO 13485 compliant operations. San Diego HQ, on-site.