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Optain
Posted 17 days agoVerified live 16h ago

Product Operations and Support Specialist

Brief overview

Remote
UndergradOr in progress
3+ yrsMinimum
Technical SupportSoftware as a Medical Device (SaMD)Medical Device TroubleshootingHardware-Software IntegrationQuality Management SystemsMedical Device Complaint HandlingFDA 21 CFR 820 / QMSRISO 13485EU MDREHR IntegrationsTelemedicineClinical Workflows

About the company

Optain’s non-invasive clinical support tools harness the power of AI-enabled algorithms to analyse retinal images to screen for disease

Job description

Summary

Optain is a healthcare technology company using AI, machine learning, and integrated hardware-software solutions to improve the detection and management of eye and systemic conditions. The Product Operations and Support Specialist will provide Tier 2 support for Optain’s robotic retinal camera and supporting software, manage device complaints, enable Customer Success, improve internal operations, and translate customer issues into product improvements.

Responsibilities

  • Serve as Tier 2 support for customers who escalate device feedback, complaints, and semi-technical product issues; reproducing, diagnosing, and resolving problems across the hardware-software boundary, distinguishing camera or hardware faults from software, image-quality, connectivity, EHR-integration, or user technique issues
  • Capture, document, and route device feedback and complaints in line with Optain’s quality management system and applicable regulations (e.g., FDA 21 CFR 820 / QMSR), recognizing when feedback may constitute a reportable complaint or potential adverse event and escalating appropriately to Quality and Regulatory
  • Support the Customer Success team with semi-technical product and onboarding questions, acting as the bridge between front-line CS and Engineering support. Contribute to knowledge base articles, troubleshooting guides, and training resources that enable CS to resolve more issues independently
  • Own internal operations and projects for the product team, including specifying requirements for internal support tooling, improving support and complaint-handling workflows, and coordinating cross-functional projects from intake to delivery
  • Support Quality in tracking and analyzing support and complaint trends, translate recurring problems into prioritized product improvement recommendations, and serve as a voice of the customer within the product organization
  • Partner closely with Product, Engineering, Quality, Regulatory, and Customer Success to ensure issues are resolved quickly while meeting the documentation rigor required of a regulated medical device

Skills

  • 3+ years in technical support, product support, application support, or product operations for software as a medical device (SaMD), or combined hardware software medical device product
  • Demonstrated ability to troubleshoot across hardware-software boundaries, isolating whether a problem originates in a hardware device, software, image quality, connectivity, or user technique. Ability to reproduce issues occurring on equipment at a remote customer site
  • Familiarity working within a quality management system and complaint-handling processes in a regulated environment (e.g., FDA 21 CFR 820 / QMSR, ISO 13485, or EU MDR), including an understanding of when an issue may be a reportable complaint or adverse event
  • Strong written communication, with a track record of building knowledge base articles, runbooks, or training that enables less-technical teammates to resolve issues independently. Demonstrated ability to explain technical concepts clearly to non-technical users
  • Operational initiative and project ownership experience, including gathering requirements for internal tools or processes, prioritizing competing work, and driving cross-functional projects to completion with minimal oversight in a remote team setting
  • Bonus: experience with imaging medical devices, telemedicine, EHR integrations, or clinical workflows in a primary care or point-of-care setting

Qualifications

Must Haves

  • 3+ years in technical support, product support, application support, or product operations for software as a medical device (SaMD), or combined hardware software medical device product
  • Demonstrated ability to troubleshoot across hardware-software boundaries, isolating whether a problem originates in a hardware device, software, image quality, connectivity, or user technique. Ability to reproduce issues occurring on equipment at a remote customer site
  • Familiarity working within a quality management system and complaint-handling processes in a regulated environment (e.g., FDA 21 CFR 820 / QMSR, ISO 13485, or EU MDR), including an understanding of when an issue may be a reportable complaint or adverse event
  • Strong written communication, with a track record of building knowledge base articles, runbooks, or training that enables less-technical teammates to resolve issues independently. Demonstrated ability to explain technical concepts clearly to non-technical users
  • Operational initiative and project ownership experience, including gathering requirements for internal tools or processes, prioritizing competing work, and driving cross-functional projects to completion with minimal oversight in a remote team setting

Nice to Haves

  • Bonus: experience with imaging medical devices, telemedicine, EHR integrations, or clinical workflows in a primary care or point-of-care setting

Benefits

  • Performance-based bonus
  • The chance to earn equity upside in Optain
  • Top-tier health, vision, and dental benefits
  • Generous monthly health and wellness reimbursement
  • This role is scoped to grow. As the US footprint expands, we expect the person in it to take on broader ownership of customer operations.
  • Unparalleled exposure to business scaling at the intersection of artificial intelligence and healthcare.
  • The opportunity to help solve difficult problems and collaborate with world-class experts from healthcare provider networks, academia, and industry.
  • A chance to work with a highly talented, close-knit team and world-leading mentors who can act as a support network and sounding board throughout your professional journey.
  • U.S.-based remote role

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