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 concerns, audit observations, CAPA activities, or compliance-related findings.
• Support validation recovery and stabilization activities for regulated systems requiring enhanced governance, traceability, testing coverage, or quality oversight improvements.
• Other duties as assigned.

REQUIREMENTS

EDUCATION & TRAINING

• Bachelor's degree in Information Technology, Computer Science, Engineering, Life Sciences, or related discipline required or equivalent combination of education/experience.
• Advanced degree preferred.
• Relevant certifications such as ASQ CQE/CQA, RAC, ISO 13485 Lead Auditor, or cybersecurity certifications are a plus.

EXPERIENCE

• 10+ years of experience in regulated software validation, software quality engineering, CSA/CSV, or regulated compliance environments. Direct experience supporting software used in Class III implantable medical devices (ophthalmic devices, other implantable devices, or other high-risk regulated products) strongly preferred.
• 5+ years of leadership experience managing software validation or software quality engineering teams.
• Direct experience supporting FDA-regulated medical device environments and international regulatory frameworks.
• Prior experience supporting Class III implantable medical devices required/preferred
• Strong experience implementing modern Computer Software Assurance (CSA) and risk-based validation methodologies.
• Experience validating ERP, MES, CRM, eQMS, cloud-hosted, SaaS, and customer-facing regulated platforms.
• Demonstrated experience supporting Software as a Medical Device (SaMD), embedded software, clinical software systems, or software integrated with high-risk medical devices required.
• Experience implementing IEC 62304 software lifecycle processes for Class B and Class C software systems preferred.
• Experience performing software risk analysis using ISO 14971 methodologies including hazard identification, hazardous situations, risk controls, residual risk evaluation, and verification of effectiveness.
• Experience supporting cybersecurity risk assessments aligned with FDA cybersecurity guidance, SBOM expectations, vulnerability management and secure software development practices.
• Experience supporting global submissions involving software documentation for FDA, EU MDR, PMDA, NMPA, Health Canada, TGA, or equivalent authorities preferred.
• Experience supporting design history files (DHF), software files, risk files, and technical documentation associated with implantable devices preferred.
• Experience operating within Agile or hybrid SDLC environments.
• Experience with Oracle Fusion ERP, Salesforce platforms, and custom .NET applications strongly preferred.
• Experience supporting global manufacturing operations and regulated cloud technologies preferred.
• Experience leading remediation initiatives, validation recovery efforts, CAPA programs, or software quality transformation initiatives strongly preferred.
• Experience implementing risk-based Computer Software Assurance (CSA) methodologies and critical scenario validation strategies preferred.

SKILLS

• Strong knowledge of FDA software guidance including General Principles of Software Validation, CSA guidance, software documentation expectations, cybersecurity guidance, AI/ML considerations, and design control requirements.
• Strong knowledge of 21 CFR Part 11, 21 CFR Part 820 (QSR), ISO 13485, IEC 62304, ISO 14971, EU MDR, and Data Integrity (ALCOA) principles, IEC 82304-1, IEC 81001-5-1, IEC 62366 usability engineering, US FDA cybersecurity expectations, and secure development practices.
• Deep understanding of software design controls, traceability, fit-for-purpose validation principles, software hazard analysis, FMEA/FTA methods, risk control verification, anomaly management, software maintenance activities, and post-market software surveillance.
• Ability to apply validation rigor based on patient risk, operational criticality, software complexity, product quality impact, and business risk.
• Strong understanding of remediation governance, CAPA processes, defect management, release risk management, and validation lifecycle recovery activities.
• Familiarity with IEC 62304 software lifecycle expectations and Software as a Medical Device (SaMD) operational considerations3 preferred.
• Strong understanding of Agile validation models, risk-based testing methodologies, and modern cloud/SaaS operational realities.
• Ability to apply validation rigor based on system criticality, patient risk, product quality impact, and operational risk.
• Deep understanding of validation traceability, testing strategies, change management, release governance, and defect management.
• Strong understanding of cybersecurity and data integrity considerations within regulated environments.
• Ability to partner effectively with Engineering, IT, QA, Regulatory Affairs, Manufacturing, and executive leadership.
• Excellent analytical, organizational, communication, and leadership skills.
• Demonstrated leadership driving modernization and operational maturity initiatives.
• Ability to scale validation organizations pragmatically while maintaining strong compliance and inspection readiness.

Pay range: $200K - $240K - Final compensation will depend on experience.

STAAR Surgical is an Equal Opportunity/Affirmative Action employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status, or any other characteristic protected by law.