Senior Automation Engineer - Scale biosensor manufacturing

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

PTO & holidays

Job summary

Biolinq, Inc. is seeking a senior-level Automation Engineer to design, qualify, deploy, and sustain automation equipment and fixtures for our digital biosensor manufacturing processes. You will develop URS documents, lead cross-functional teams, and partner with external vendors to implement scalable solutions.

The role emphasizes DOE, statistical analysis, and robust validation strategies to ensure quality, efficiency, and cost-effectiveness in production; travel is expected < 20%. This is a hands-on leadership position with significant impact on manufacturing performance.

Qualifications

• BS degree in mechanical, manufacturing, electrical engineering or related field
• 8–12 years related experience; higher degrees may count
• Experience designing, qualifying automated manufacturing equipment
• Experience leading automation projects through full lifecycle (Requirements, Build, FAT/SAT, Deployment)
• DOE, statistical analysis and root cause investigation
• Strong understanding of manufacturing process control and scale-up
• Experience with capital planning, ROI/NPV analyses
• Familiarity with FDA 21 CFR Part 820, ISO 13485, and equipment validation
• Experience with industrial automation tech: PLC/HMI, robotics, machine vision, sensors
• Lean, Six Sigma, and design for manufacturability preferred
• Strong leadership and cross-functional collaboration
• Proficient in SolidWorks and CAD
• Experience with MES and industrial control systems
• Strong problem solving and decision making

Responsibilities

• Develop fixtures and automation solutions for R&D and manufacturing
• Design, prototype, evaluate, and deploy robust fixtures for process characterization and manufacturing scale-up
• Identify opportunities to automate manual processes to improve quality and efficiency
• Develop user requirements and equipment specifications for automation equipment and fixtures
• Manage equipment lifecycle from URS through FAT/SAT, qualification, deployment and sustaining support
• Lead external automation vendors and system integrators with budgets, schedules and plans
• Lead technical reviews of architecture, controls, mechanics, software, and validation strategy
• Review designs for manufacturability, serviceability and scalability
• Develop qualification protocols, acceptance criteria and preventative maintenance
• Design experiments to characterize and optimize equipment and process performance

Skills

Leadership

DOE

Statistical analysis

Automation systems

Manufacturing experience

Education

BS in Mechanical/Manufacturing/Electrical or related field

MS or PhD preferred

Tools

SolidWorks

PLC/HMI

MS Office

BMRAM

MES

Job description

Biolinq, Inc. is seeking a senior-level Automation Engineer to design, qualify, deploy, and sustain automation equipment and fixtures for our digital biosensor manufacturing processes. You will develop URS documents, lead cross-functional teams, and partner with external vendors to implement scalable solutions.

The role emphasizes DOE, statistical analysis, and robust validation strategies to ensure quality, efficiency, and cost-effectiveness in production; travel is expected < 20%. This is a hands-on leadership position with significant impact on manufacturing performance.