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Horizon Surgical Systems · 1 month ago

Senior NPI and Manufacturing Engineer

Los Angeles, California

Full-time

Onsite

Senior Level

$130K/yr - $170K/yr

5+ years exp

Horizon Surgical Systems Inc. is revolutionizing the world of surgical ophthalmology by developing a novel, AI driven, and imaging-guided surgical robotic system. They are seeking a hands-on, resourceful Sr. NPI and Manufacturing Engineer to lead the development of their pilot manufacturing line for eye surgery robots, focusing on creating and maintaining manufacturing processes and documentation.

Artificial Intelligence (AI)Health CareRobotics

H1B Sponsor Likely

Responsibilities

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

Set up and organize pilot-scale manufacturing space, including workstations, tools, and test rigs. Lead process validation (IQ, OQ, PQ) including protocol writing, execution, and report writing

Design and set up cleanroom or controlled-environment assembly areas including ESD controls, particulate monitoring, and gowning procedures

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

Contribute to Design for Manufacturability (DFM) and drive yield improvement activities

Design assembly fixtures, test fixtures, and custom tooling to improve repeatability and yield

Identify, qualify, and manage key suppliers for critical components. Establish incoming inspection processes and supplier quality agreements

Support design transfer by working closely with R&D engineers to make prototypes manufacturable and repeatable

Implement traceability systems for parts, subassemblies, and final builds

Perform and document verification/validation for clinical studies

Lead root-cause investigation for non-conformances, CAPAs, and post-market complaints during clinical and early commercial phases

Drive cost-of-goods-sold (COGS) reduction efforts and create a phased manufacturing scale-up plan from pilot to low-volume production

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

Train and oversee assembly technicians as the team grows

Qualification

Medical device manufacturingNew product introductionElectromechanical systemsDesign controlsRegulated manufacturing documentationAdvanced degreeRobotics experienceOptics experienceSurgical instruments experienceSmall-scale manufacturingFDA QSR exposureISO 13485 auditsProblem-solving skillsCross-functional collaboration

Required

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

5+ 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

Experience setting up small-scale manufacturing environments

Exposure to FDA QSR / ISO 13485 audits

Benefits

Stock options

End of year bonus

Full suite of health benefits

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)