Product Operations and Support Specialist
New
O
OptainHealthTech
Remote within the U.S.Full-TimeMiddle
SalaryCompetitive compensation package, including a strong base salary, performance-based bonus, and the chance to earn equity upside in Optain.
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Job Details
- Experience
- 3+ years
- Required Skills
- Project ManagementProduct OperationsTroubleshootingTechnical support
Requirements
- 3+ years of experience in technical, product, or application support for SaMD or hardware-software medical devices.
- Proficiency in troubleshooting across hardware-software boundaries (hardware, software, connectivity, or user technique).
- Familiarity with quality management systems and complaint-handling processes (e.g., FDA 21 CFR 820, QMSR, ISO 13485, or EU MDR).
- Ability to recognize and escalate reportable complaints or adverse events.
- Strong written communication skills with experience building knowledge base articles and technical training documentation.
- Proven experience in project ownership, gathering internal tool requirements, and driving cross-functional projects.
- Demonstrated ability to work independently in a remote team setting.
- Experience with imaging medical devices, telemedicine, or EHR integrations is a plus.
Responsibilities
- Serve as Tier 2 support for customers escalating device feedback, complaints, and semi-technical product issues.
- Diagnose and resolve problems across hardware-software boundaries, including connectivity, image quality, and EHR integrations.
- Document device feedback and complaints in compliance with FDA 21 CFR 820 / QMSR quality management standards.
- Support Customer Success by creating knowledge base articles, troubleshooting guides, and training resources.
- Own internal operations and projects for the product team, including defining requirements for support tooling.
- Track and analyze support/complaint trends to provide product improvement recommendations to Engineering.
- Partner with Product, Quality, and Regulatory teams to ensure documentation rigor for medical devices.
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