Senior Automation Engineer

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

Description

About The Company

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.

Job Purpose

Responsible for activities and area goals through design, development, qualification, deployment, and sustaining of automation equipment and production fixtures at the component and finished product level.

Duties And 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

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;
• Experience with lean manufacturing, six sigma, and design for manufacturability principles (preferred);
• 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;
• Experience with manufacturing databases, MES, and industrial control systems (preferred);
• Strong organizational, problem solving, and decision-making skills with a proven ability to deliver results across teams, projects, and programs

Working Conditions

General Office, Laboratory, and Cleanroom environments

Expected travel less than 20%

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to handle or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee may occasionally lift/or move up to 15 pounds.

Benefits

Medical, dental, vision, health savings account, flexible spending account, life and long-term disability insurance, 401(k) plan, holidays, and PTO.

At Biolinq we fully subscribe to the principles of Equal Employment Opportunity. It is our policy to provide employment, compensation, and other benefits related to employment based on qualifications, without regard to race, color, religion, national origin, age, sex, veteran status, genetic information, disability, or any other basis prohibited by federal, state or local law. In accordance with requirements of the Americans with Disabilities Act and applicable federal, state and/or local laws, it is our policy to provide reasonable accommodation upon request during the application process to applicants in order that they may be given a full and fair opportunity to be considered for employment. As an Equal Opportunity Employer, we intend to comply fully with applicable federal, state and/or local employment laws and the information requested on this application will only be used for purposes consistent with those laws. To the extent required by applicable law, The Company maintains a smoke- free workplace.

As part of our efforts to ensure fair and equal pay based on merit, Biolinq supports pay transparency internally and during the recruitment process. The U.S. base salary range reasonably expected to be paid for this role is: $110,000 to $125,000 per year. We may ultimately pay more or less than the posted range. Actual compensation packages are commensurate with experience and based on a variety of factors that are unique to each candidate including, but not limited to: skill set, depth of experience, education, certifications, and specific work location. The range displayed reflects the minimum and maximum target for new hire salaries for the job across the U.S. The total compensation package for this position may also include an annual performance bonus and/or other applicable incentive compensation plans. Biolinq also offers a comprehensive package of benefits including paid time off (vacation, holidays, sick time, parental leave), medical/dental/vision insurance, and 401(k) to eligible employees, subject to the terms and conditions of the applicable plans and any written agreement between the parties. Your recruiter can share more about the total compensation package during the hiring process.

Please note: The information contained herein is not intended to be an all-inclusive list of duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.