• Directed and led the Design Quality organization with a primary focus on Design Controls and ISO 14971 compliant risk management throughout the entire product lifecycle. Oversaw risk analyses (hazard risk analysis, software risk, dFMEA, cybersecurity risk, usability risk) and ensured systematic identification, evaluation, and control of hazards in collaboration with R&D, Systems Engineering, Operations, Supply Chain, and Regulatory Affairs.

• Ensured full alignment of design and development activities with 21 CFR 820.30, ISO 13485, and ISO 14971 requirements, including robust traceability from user needs, design inputs, verification/validation, risk controls, design transfer. Strengthened QMS adherence by driving consistent application of design reviews, requirements management, architectural documentation, and post-market risk monitoring.

• Drove post-market surveillance to feed new risk signals back into the Design Control process and prevent recurrence, recalls, or field actions.

• Led cybersecurity, AI/ML risk analysis, and Secure-by-Design integration into Design Controls, including SBOM lifecycle management, AI-specific hazard identification, model-change controls, and compliance with FDA PCCP, NIST AI RMF, and EU AI Act. Served as Quality and Cybersecurity Lead for machine-learning algorithms, participating in FDA submissions, responding to Regulatory inquiries, and ensuring AI performance, safety, and risk controls remained representative of real-world use.

• Managed Supplier Quality and Manufacturing Quality processes to ensure validated, controlled, and compliant design transfer, including supplier qualification, NCR/CAPA oversight, incoming inspection, and continuous monitoring of supplier-introduced risk.

• Implemented and maintained comprehensive Design Control processes to ensure safe, effective, and compliant medical devices across the full product lifecycle. Strengthened traceability from user needs through design inputs, verification/validation, design transfer, and post-market feedback. Ensured alignment with QSR 21 CFR 820.30, ISO 13485, EU MDR, and Health Canada requirements. Managed the Quality Design Engineering group with direct responsibility for ISO 14971 compliant risk management activities. Oversaw design-impact assessments for changes, nonconformance evaluation (NCM), complaint investigations, CAPA effectiveness checks, and product quality trending to maintain controlled design-state decision making.

• Led the Cybersecurity Design Control process, embedding security-by-design and modern threat modeling into requirements, architecture, and verification activities. Conducted vulnerability assessments across embedded software, cloud systems, and data flows. Implemented the Cybersecurity Incident Reporting process and led post-market surveillance using SBOMs, coordinated vulnerability disclosure (CVD), and ongoing monitoring of exploit trends.

• Represented Nevro as a subject-matter expert in cybersecurity, interoperability, and medical device safety, participating in HSCC, Health-ISAC, MDIC, MITRE, AdvaMed, and CISA working groups to shape industry-wide best practices, especially around SBOM requirements, secure development lifecycles, and cross-vendor compatibility.

• Served as Quality Leader for multiple software and platform initiatives, ensuring quality and risk controls were properly defined, implemented, and verified at each design phase. Strengthened Software Quality Assurance by integrating Design Control checkpoints into program milestones.

• Provided expert guidance on Computer Systems Validation (CSV) and ensured all systems, cloud environments, and software tools remained compliant with FDA expectations and industry frameworks.

• Directed the development, implementation, and maintenance of the quality management system (QMS), establishing robust design-control frameworks, risk processes, and quality tools aligned with the company’s strategic goals. Oversaw Quality Management Review and Product Quality Review processes, while providing critical support for FDA submissions.

• Defined and implemented the Software Development Lifecycle (SDLC) to ensure compliance with ISO 62304, embedding requirements traceability, verification rigor, hazard mitigation, and software risk controls to support the development of safe, reliable, and high-quality medical device software.

• Led the strategic development, deployment, and improvement of regulated computerized systems, including ServiceCloud, QAD, Arena, Helix, and custom-built systems for formal verification and medical device software development. Conducted periodic reviews of SOPs, Quality Agreements, and training metrics to ensure controlled processes and sustained workforce competency.

• Served as Technical Leader for requirements elicitation and detailed design discussions with cross-functional teams, including software developers, R&D, hardware engineers, architects, program managers, and quality/regulatory personnel. Partnered closely with R&D to create and maintain a Secure Product Development Lifecycle and ensure that Information Security requirements/controls were embedded throughout the design process.

• Provided leadership and oversight of commercial manufacturing processes and product releases, working alongside Operations, R&D, Supply Chain, and Regulatory Affairs teams. Identified and implemented opportunities for improving data quality and addressing issues through proactive error detection, correction, and process optimization.

• Collaborated daily with multi-disciplinary project teams, including functional/program managers, engineering staff, plant personnel, customer site teams, and suppliers to drive New Product Introductions.

• Led interdisciplinary teams in conducting risk-based threat assessments to evaluate and refine system architecture, incorporating industry best practices.

• Partnered with cybersecurity teams across the organization to enhance processes and establish a unified approach to cybersecurity.

• Directed teams to analyze critical design trade-offs, optimizing system operation for security, usability, and complexity.

• Developed product-specific quality plans and conducted comprehensive production readiness assessments, ensuring completion of all key quality and verification deliverables.

• Engaged with suppliers to address quality and cybersecurity concerns, driving timely root cause analyses and implementing corrective and preventive actions for materials and systems.

• Conducted internal and external audits to ensure compliance with quality and security standards.

• Hosted factory acceptance testing for foreign government representatives, requiring security clearance and ensuring adherence to stringent quality and security requirements.

• Technical Lead of the Process Excellence team, driving initiatives to identify and address major root causes of field and manufacturing failures. Successfully resolved 84 optical alignment issues and implemented 55 engineering activities under a standardized process and Kaizen plan to improve manufacturing efficiency.

• Identified and resolved the root cause of the "Black Screen of Death" (BSOD) issue, which accounted for 15–20% of manufacturing failures. Mitigated the Cost of Poor Quality (COPQ) of ~$300K in material replacements and recovered $1.0M in revenue losses (2014).

• Served as a core team member for all new product introductions, contributing to risk analysis, design improvements, and seamless transitions to manufacturing.

• Participated in failure investigations to analyze system and process failures, integrating cybersecurity intelligence and employing a risk-based approach to assess vulnerabilities and their impact on device functionality and clinical risk.

• Developed and presented cradle-to-grave dashboards during Sustaining forums, providing detailed life-cycle metrics and highlighting the top five product issues, including the status of corrective actions (CAPAs) and supplier corrective action requests (SCARs).

• Managed the Complaints Process for the Hayward site, defining procedures, validating tools, and ensuring compliance with regulatory requirements.

• Authored, reviewed, and approved Quality System documentation, including SOPs, Work Instructions (WI), Test Methods, Specifications, Protocols, Reports, and Quality Plans. Led the implementation of the change control process and oversaw the successful transition to the SAP system to enhance process integration and efficiency.