Senior Automation Engineer

Biolinqorporated • San Diego, CA

17h • Onsite

About The Position

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.

Requirements

• BS Degree in Mechanical Engineering, Manufacturing Engineering, Electrical Engineering, or scientific discipline required
• Minimum 8-12 years related experience, including years of higher-level education (MS, PhD)
• Experience specifying, designing, implementing, and qualifying automated manufacturing equipment and fixtures
• Experience leading automation projects through requirements development, design review, build, FAT, SAT, and deployment
• Experience with design of experiments (DOE), statistical analysis, and root cause investigation methodologies
• Strong understanding of process interactions, system interaction, and manufacturing process control
• Expertise scaling manufacturing processes, equipment, and automation systems to commercial volumes
• Experience with capital planning, cost analysis, and business case development (ROI, NPV)
• Strong understanding of FDA 21 CFR Part 820, ISO 13485, and equipment validation requirements
• Experience with industrial automation technologies, including controls, PLC/HMI systems, robotics, machine vision, sensors, and equipment integration
• Strong leadership skills with the ability to influence cross-functional teams, prioritize resources, and drive execution
• Proficiency in Microsoft Office and project management tools
• Proficiency in BMRAM or equivalent asset management system
• Proficiency in SolidWorks or equivalent CAD software
• Strong organizational, problem solving, and decision-making skills with a proven ability to deliver results across teams, projects, and programs

Nice To Haves

• Experience with lean manufacturing, six sigma, and design for manufacturability principles
• Experience with manufacturing databases, MES, and industrial control systems

Responsibilities

• Support R&D and Manufacturing Engineering with development of fixtures and automation solutions enabling product and process development
• Develop processes, fixtures, and equipment that meet business and manufacturing needs
• Design, prototype, evaluate, and deploy robust fixtures for process characterization, engineering builds, verification activities, and manufacturing scale-up
• Identify opportunities to automate manual processes to improve quality, capacity, repeatability, and cost
• Develop user requirements and equipment specifications (URS, ERD) for automation equipment and fixtures
• Manage equipment lifecycle through requirements development, design review, FAT/SAT, qualification, deployment, and sustaining support
• Partner with external automation vendors and system integrators to develop equipment concepts, schedules, budgets, and implementation plans
• Lead technical reviews of automation system architecture, controls, mechanical design, software, safety systems, and validation strategy
• Review equipment and fixture designs to ensure manufacturability, serviceability, operator usability, and scalability
• Develop risk assessments, qualification protocols, acceptance criteria, and preventative maintenance requirements for equipment and fixtures
• Design experiments to characterize and optimize equipment, fixtures, and process performance using standard engineering and statistical methods
• Partner with Quality and Validation teams to support equipment qualification activities
• Complete root cause investigations related to equipment, tooling, automation systems, and process performance and implement sustainable corrective actions
• Optimize equipment and fixture designs to improve quality, efficiency, capacity, and process repeatability at the lowest cost
• Develop capital plans and cost models to support automation investments, capacity expansion, and manufacturing scale-up
• Support evaluation, selection, development, and qualification of automation suppliers, integrators, and manufacturing partners
• Manage automation project execution with external vendors to ensure delivery of scope, schedule, budget, and performance objectives
• Develop business processes, standards, and tools that improve equipment deployment, manufacturing execution, and automation capability
• Provide the voice of manufacturing and automation to ensure successful transfer from R&D into production and future product generations

Benefits

• Medical, dental, vision, health savings account, flexible spending account, life and long-term disability insurance, 401(k) plan, holidays, and PTO
• paid time off (vacation, holidays, sick time, parental leave)

What This Job Offers

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