Senior NPI and Manufacturing Engineer

Open Position –  Senior NPI and Manufacturing Engineer 

Horizon Surgical Systems Inc.

Horizon Surgical Systems Inc. is revolutionizing the world of surgical ophthalmology by developing a novel, AI driven, and imaging-guided surgical robotic system. Horizon Surgical Systems Inc. aims to expand access to care, provide superior capabilities to the human surgeon, and enhance patient outcomes. Microsurgery in general and Ophthalmology are subfields of surgery for which the surgical outcomes can be significantly improved by robotic systems to allow superior dexterity, precision, accuracy, and visualization beyond the human surgeon’s own capabilities.

We are seeking highly motivated, and intellectually inquisitive individuals looking to make a positive impact on healthcare via the development of robotic technology. The core values of Horizon Surgical Systems Inc. are:

• Commitment to Excellence: We aim to deliver superior patient outcomes and surgeon experiences
• Passion for Creativity and Innovation: We are driven by new ideas and aim to push the boundaries of what's possible
• Teamwork and Camaraderie: We achieve our best when we collaborate and work together
• Welcoming of Critical Opinion: We are enriched by constructive criticism and support the best ideas
• Personal Accountability: We honor our commitments and take responsibility for our actions

Horizon Surgical Systems Inc. offers:

• An opportunity to build autonomous surgical robotic systems driven by image guidance and AI technology for the future of affordable, high-quality healthcare.
• The opportunity to work alongside clinicians, engineers, and global leaders in cutting-edge AI, imaging, and robotics technology.
• Competitive compensation and an excellent company-paid benefits package.

Horizon Surgical Systems is an innovative medical device startup developing the first ever robotic system to perform cataract surgery. We are entering an exciting growth phase as we transition from R&D to pilot-scale manufacturing and prepare for clinical and regulatory milestones.

We’re looking for a hands-on, resourceful Sr. NPI and Manufacturing Engineer to lead the development our pilot manufacturing line for eye surgery robot. This role is ideal for someone who thrives in fast-paced, startup environments and wants to shape the foundation of a scalable, compliant production operation.

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.

Qualifications

Must-Have

• 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.

Nice-to-Have

• Advanced degree
• Experience with robotics, optics, or surgical instruments.
• Experience setting up small-scale manufacturing environments.
• Exposure to FDA QSR / ISO 13485 audits.

This is an exciting opportunity to join a high-tech startup that is poised to revolutionize surgical robotics in ophthalmology.