Product Director, Digital Health

Description

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

ESSENTIAL DUTIES AND 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.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

• 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.

Success Indicators

• Successful FDA submissions and approvals.
• Strong adoption by clinicians, patients, and internal teams.
• Measurable improvements in user experience and clinical outcomes.
• Scalable and compliant connected systems that support global markets.

SUPERVISORY RESPONSIBILITIES

• No direct supervisory requirements
• Ability to direct project teams with direct project responsibility with no personnel responsibility

EDUCATION, EXPERIENCE, and TRAINING

• 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

CERTIFICATES, LICENSES, REGISTRATIONS

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

COMPUTER SKILLS

• MS Office Products
• Cloud database (Azure, AWS, Salesforce, etc.)

Notice to Staffing Agencies and Search Firms

RxSight does not accept unsolicited resumes or candidate submissions from staffing agencies or search firms for any employment opportunities. All agency engagements must be authorized in writing for a specific position by RxSight’s Talent Acquisition department. Any resumes or candidate information submitted without such specific engagement will be considered unsolicited and the property of RxSight. No fees will be paid in the event a candidate is hired under these circumstances.

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