Senior Automation Engineer - Medical Device Manufacturing

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

PTO

Holidays

Job summary

Biolinq in San Diego is seeking an experienced engineer to design, develop, qualify, deploy, and sustain automation equipment and fixtures at the component and finished product level.

You will lead automation projects, collaborate with R&D and Manufacturing, and ensure manufacturability, scalability, and cost efficiency while meeting regulatory requirements. This role involves CAD, DOE, and working with external vendors to optimize processes.

Qualifications

• BS degree in mechanical, manufacturing, electrical engineering or related field.
• 8–12 years of related experience; MS/PhD considered advantageous.
• Experience specifying, designing, implementing and qualifying automated equipment.
• Experience leading automation projects through design, FAT/SAT, and deployment.
• DOE, statistical analysis, and root cause investigation experience.
• Knowledge of FDA 21 CFR Part 820, ISO 13485 and equipment validation.

Responsibilities

• Develop, qualify, and deploy automation equipment and fixtures.
• Lead automation projects with external vendors; manage scope, schedule, budget.
• Create URS/ERD and qualification protocols; perform risk assessments.
• Improve quality, capacity, and cost through automation improvements.
• Collaborate with R&D and Manufacturing for scale-up and transfer.

Skills

Leadership

Problem solving

Decision making

Organization

Education

BS in Mechanical Engineering / Manufacturing Engineering / Electrical Engineering or related

MS or PhD preferred

Tools

SolidWorks

CAD

Microsoft Office

BMRAM

MES

Job description

Biolinq in San Diego is seeking an experienced engineer to design, develop, qualify, deploy, and sustain automation equipment and fixtures at the component and finished product level.

You will lead automation projects, collaborate with R&D and Manufacturing, and ensure manufacturability, scalability, and cost efficiency while meeting regulatory requirements. This role involves CAD, DOE, and working with external vendors to optimize processes.