Horizon Surgical Systems Inc. is revolutionizing the world of surgical ophthalmology by developing a novel, AI driven, and imaging-guided surgical robotic system. We are seeking highly motivated, and intellectually inquisitive individuals looking to make a positive impact on healthcare via the development of robotic technology.
Requirements
- 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.
Benefits
- Competitive compensation
- Excellent company-paid benefits package
- Stock options
- End of year bonus
- Full suite of health benefits
