Senior Automation Engineer - Biotech Manufacturing & R&D

Biolinq, Inc.; San Diego (CA); On-site; USD 110,000 - 125,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) plan

Paid time off

Job summary

Biolinq, Inc. is seeking an experienced automation specialist to design, develop, and deploy fixtures and automated equipment for its intradermal biosensor platform. You will qualify solutions, write URS/ERD, and partner with vendors to ensure manufacturability and scalability in a lab-to-production environment.

The role emphasizes DOE, statistical analysis, and robust validation, with travel less than 20%. Strong leadership and cross-functional collaboration are essential.

Qualifications

• Experience with automated manufacturing equipment and fixtures.
• DOE, statistical analysis, and RCA methodologies.
• FDA 21 CFR Part 820 and ISO 13485 familiarity.
• Lean manufacturing and Six Sigma experience preferred.
• Strong cross-functional leadership and project management.

Responsibilities

• Design, develop, qualify, deploy, and sustain automation equipment and fixtures.
• Lead automation projects from requirements through deployment and sustaining support.
• Develop URS/ERD for automation equipment and fixtures.
• Collaborate with external vendors and system integrators on concepts and plans.
• Perform risk assessments and qualification protocols for equipment.
• Drive cost, quality, and capacity improvements in manufacturing.

Education

BS Degree in Mechanical/Manufacturing/Electrical Engineering

Tools

SolidWorks

PLC/HMI systems

Machine vision

CAD software

Job description

Biolinq, Inc. is seeking an experienced automation specialist to design, develop, and deploy fixtures and automated equipment for its intradermal biosensor platform. You will qualify solutions, write URS/ERD, and partner with vendors to ensure manufacturability and scalability in a lab-to-production environment.

The role emphasizes DOE, statistical analysis, and robust validation, with travel less than 20%. Strong leadership and cross-functional collaboration are essential.