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Horizon Surgical Systems · 1 day ago

Manufacturing Manager/Director

Los Angeles, California

Full-time

Onsite

Director/Executive

7+ years exp

Horizon Surgical Systems Inc. is revolutionizing surgical ophthalmology with an innovative AI-driven robotic system. They are seeking a hands-on Manufacturing Manager/Director to lead the establishment and operation of their pilot manufacturing facility, focusing on developing assembly processes and ensuring compliance with regulatory standards.

Artificial Intelligence (AI)Health CareRobotics

H1B Sponsor Likely

Responsibilities

Develop and maintain assembly and test processes for robotic, electronic, and optical sub-systems

Set up and organize pilot-scale manufacturing space, including workstations, tools, and test rigs. Perform process validation (IQ,OQ,PQ)

Set-up supply chain operation team

Create and own manufacturing documentation: Device Master Record (DMR), Device History Record (DHR), work instructions, travelers, and test logs

Support design transfer by working closely with R&D to make prototypes manufacturable and repeatable by revising processes based on lessons learned

Implement traceability systems for parts, subassemblies, and final builds

Develop and implement facility safety procedures

Perform and document verification/validation and clinical studies

Collaborate with Quality to ensure compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 14971 requirements

Assist in qualifying suppliers and contractors for key components (machined parts, PCBAs, optics)

Train and oversee assembly technicians as the team grows

Continuously improve efficiency, reliability, and compliance of the build process

Qualification

Medical device manufacturingElectromechanical systemsRegulated manufacturing documentationLean manufacturingRobotics experienceAssemblyTestingProblem-solving skillsCross-functional collaboration

Required

Bachelor's degree in Mechanical, Electrical, Manufacturing, or related engineering field

7+ years of experience in medical device manufacturing, pilot production, or new product introduction

Hands-on experience with assembly, testing, and troubleshooting of complex electromechanical systems

Familiarity with design controls, DMR/DHR, and regulated manufacturing documentation

Strong problem-solving skills and ability to work cross-functionally in a startup environment

Preferred

Advanced degree

Experience with robotics, optics, or surgical instruments

Knowledge of lean manufacturing

Experience setting up small-scale manufacturing environments

Exposure to FDA QSR / ISO 13485 audits

Benefits

Competitive compensation

Excellent company-paid benefits package

Company

Horizon Surgical Systems

Horizon Surgical Systems develops AI-driven, imaging-guided surgical robotics for microsurgery.

Founded in 2021

Malibu, California, USA

51-200 employees

https://www.horizonsurgicalsystems.com

H1B Sponsorship

Horizon Surgical Systems has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (1)

2024 (2)