Product Director, Digital Health

RxSight, Inc.•Aliso Viejo, CA

About The Position

RxSight® is an ophthalmic medical technology corporation headquartered in Aliso Viejo, California that has commercialized the world’s first and only adjustable intraocular lens (IOL) that is customized after cataract surgery. The company’s mission is to revolutionize the premium cataract surgery experience by allowing surgeons to partner with their patients to achieve optimized results for every unique eye. OVERVIEW: The Product Director, Digital Health leads the strategy, development, and lifecycle management of digitally connected medical device products and platforms. This role directs initiatives that combine IoT-enabled devices, wireless communication technologies, cloud database ecosystems, and clinical-grade software to deliver safe, compliant, and innovative digital health solutions. Products are used by internal stakeholders and external users, requiring rigorous FDA (including EU and other international markets), quality, and cybersecurity standards.

Requirements

Experience with non-medical devices (NMD), software as a medical device (SAMD), and class II/III devices.
Experience supporting FDA submissions (510(k), De Novo, PMA).
Deep knowledge of IoT, wireless protocols, embedded systems, and cloud platforms.
Experience with Design Controls, risk management, IEC 62304.
Strong leadership and communication skills.
Knowledge of HL7, FHIR, DICOM.
Cybersecurity background.
Experience with clinical trials or real-world evidence.
Bachelor’s in Engineering, Computer Science, Biomedical Engineering, or related field.
10+ years in product management with 5+ in digital health or connected medical devices
Training to be completed per the training plan for this position as maintained in the document control system
The training requirements on TRN-10007 Insider Trading Policy, TRN-10008 Global Anti-Bribery and Anti-Corruption Policy and TRN-10009 Code of Business Conducts and Ethics must be diligently completed within 30 days from the hiring date and on an annual basis

Nice To Haves

Cybersecurity certification(s) a plus
IoT certification(s) a plus

Responsibilities

Product Strategy & Vision
Define long-term strategy for connected medical devices, digital platforms, and remote monitoring ecosystems.
Build and maintain a roadmap aligned with clinical needs, regulatory pathways, and business goals.
Identify opportunities in IoT, wireless communication, cybersecurity, and cloud technologies.
Product Development & Execution
Lead product definition for IoT sensors, embedded systems, firmware, wireless connectivity, apps, and cloud systems.
Collaborate with engineering on device-to-cloud architecture, protocols, APIs, and clinical data models.
Ensure compliance with usability, reliability, human factors, and risk controls.
Oversee database strategies supporting secure, compliant data handling.
Oversee cloud architecture decisions supporting device connectivity, data ingestion, storage, analytics, security, and availability.
FDA & Global Regulatory Collaboration
Drive FDA submission readiness across 510(k), De Novo, PMA, and software-driven connected devices.
Support Design Controls, risk management, V&V, traceability, and usability documentation.
Contribute to regulatory submissions and participate in FDA interactions.
Ensure compliance with 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601, and cybersecurity guidance.
Ensure adherence to global data protection and privacy regulations including HIPAA, GDPR, PIPEDA, APPI, PDPA, LGPD, and data-residency requirements.
Maintain compliance with international cybersecurity frameworks such as ISO 27001, IEC 81001-5-1, NIS2, FDA cybersecurity guidance.
Customer & Clinical Stakeholder Engagement
Act as liaison to clinicians, patients, internal teams, and commercial partners.
Integrate user feedback into product improvements.
Support commercialization, training materials, and post-market surveillance.
Cross-Functional Leadership
Lead cross-functional teams across R&D, engineering, cybersecurity, clinical, operations, and commercial.
Manage external partners, cloud vendors, software developers, and suppliers.
Mentor products and establish product leadership best practices.