Director, Software Validation

MAIN JOB RESPONSIBILITIES / COMPETENCIES

The Director of Software Validation is responsible for leading STAAR Surgical’s software validation organization and for software quality oversight across Information Technology related to regulated product software, Software as a Medical Device (SaMD) and software supporting STAAr’s medical devices. This role partners closely with Quality Assurance, Regulatory Affairs, Research and Development, Manufacturing, Cyber and Data Security, Infrastructure, and business stakeholders to ensure compliant, scalable, and modern validation governance across regulated enterprise, manufacturing, and Software as a Medical Device (SaMD) platforms.

This role additionally supports software quality governance, remediation, and risk-based assurance activities across regulated and Software as a Medical Device (SaMD) platforms. The position partners closely with Quality Assurance, Regulatory Affairs, Engineering, and IT leadership to strengthen validation rigor, design control alignment, operational reliability, and long-term compliance readiness.

• Lead and manage global software validation teams supporting enterprise, manufacturing, and customer-facing regulated systems.
• Define and operationalize STAAR Surgical’s Computer Software Assurance (CSA) and Computer System Validation (CSV) strategy.
• Drive transition from traditional documentation-heavy validation models toward modern risk-based CSA methodologies.
• Establish scalable validation governance supporting Agile and modern Software Development Lifecycle (SDLC) processes. Ensure software lifecycle activities comply with IEC 62304 including software safety classification, architecture review, requirements management, verification, integration testing, system testing, release controls, and maintenance activities.
• Lead validation oversight for Oracle Fusion ERP, Salesforce eB2B/SaMD platforms, custom .NET MES systems, and regulated cloud applications.
• Partner with Software Engineering, IT, QA, Regulatory Affairs, Manufacturing, and Infrastructure teams to ensure compliant and efficient release governance.
• Ensure validation rigor is proportional to patient risk, implantable device criticality, software safety classification, cybersecurity exposure, and potential impact to clinical outcomes.
• Oversee end-to-end requirements traceability from user needs, intended use, hazards, risk controls, software requirements, verification activities, validation evidence, and post-market actions.
• Ensure software validation maintains alignment with design history files (DHF), risk management files, usability engineering documentation, and clinical evidence packages.
• Support inspections/audits by regulatory agencies (ex. US FDA, EU Notified Bodies, etc.), supplier audits, and internal audit readiness activities related to software validation, design controls, cybersecurity, and software lifecycle compliance.
• Provide leadership and mentorship to validation engineers, analysts, consultants, and cross-functional teams.
• Establish standardized validation frameworks, templates, procedures, and governance models supporting global operations in the United States and Switzerland.
• Ensure systems and processes comply with FDA regulations, global medical device standards, and data integrity requirements.
• Collaborate with peers and stakeholders to modernize validation practices without creating unnecessary operational or engineering bottlenecks.
• Establish and oversee software design control governance including intended use definition, software requirements management, hazard analysis, risk control implementation, verification/validation strategy, configuration management, anomaly handling and maintenance activities.
• Implement risk-based validation methodologies focused on critical workflows, patient/product-impacting calculations, integrations, operationally sensitive functionality, and data integrity considerations. Ensure validation coverage includes algorithms, patient-impacting computations, clinical performance claims, interoperability risks, and safety-critical software functionality.
• Support remediation initiatives associated with validation gaps, software quality…