# Brindusa Curcaneanu > MedTech Quality & Compliance | Design Quality | AI & Cybersecurity Risk | Medical Device Safety | AI/ML Assurance | Systems Implementation & Validation | Scientist Location: Union City, California, United States Profile: https://flows.cv/brindusa • Active participant in the Healthcare Sector Coordinating Council Cybersecurity Working Group and NTIA. The Healthcare and Public Health Sector Coordinating Council brings together the several sub-sectors of the healthcare industry in collaboration with the government – principally the Departments of Health and Human Services, and Homeland Security - to develop and implement evolving ways to strengthen the sector’s security and resiliency against cyber and physical threats. The healthcare and public health sector is one of 16 critical industry sectors identified under Presidential Policy Directive 21. • Implementation and roll-out of QMS solutions (i.e Arena, EtQ, JAMA), Risk Management and Defect tracking systems (i.e Helix ALM, JAMA, Jira) • Over 25 yrs of industrial experience in medical device, biotech, pharma and defense industries in R&D, QMSR implementation, design engineering, software quality, cybersecurity, Artificial Intelligence, SBOM/AIBOM, manufacturing/operations, suppliers quality management, regulatory submissions, quality assurance (QA) & regulatory affairs (RA). Hosted US FDA, Canada, SFDA, notified body (BSI/TUV) and other local government and international inspections. • Solid knowledge of Information Security standards and frameworks such as NIST Cyber Security Frameworks and ISO 27002, Threat Modelling, OWASP Top 20, Penetration testing, HITRUST, Internal corporate Governance and risk management process, Vendor risk assessment/management • Strong background in helping companies establish a global Quality Management System and obtain ISO 13485 Certification, 510(k) clearance, PMA/De Novo approvals. Some of my expertise in the area of 510(k) submission involves hardware, software, electrical and mechanical components, software verification and validation, design controls, audits, risk management, security risk assessment. Specialties: • Medical Devices, 510(k) Submissions, International Marketing Clearance Strategy, CGMP, 21 CFR Parts 808, 812 and 820, Risk Analysis, FDA QSR Design Control, ISO 9001, ISO 13485, ISO 14971, IEC 62366-Usability Compliance, EN 60601-1 3rd Ed, IEC 62304 (SDLC), Software Verification and Validation, SOUP (Software of Unknown Provenance), SaMD (Software as a Medical Device), Cybersecurity, HIPAA, NIST CyberSecurity Framework (CSF), NIST 800-53 (FISMA), ISO/IEC 27001/2, ISO 15408, STIG, SCAP, IT security, CLIA lab/ISO 15189 ## Work Experience ### Sr Manager Quality & Cybersecurity @ NeuroPace Jan 2023 – Present • 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. ### Software Quality and Cybersecurity Program Manager @ Nevro Jan 2019 – Jan 2023 • 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. ### Principal Software Quality Lead @ RefleXion Medical Jan 2017 – Jan 2019 • 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. ### Sr Quality Lead- Explosive Detection Systems @ Smiths Detection Jan 2016 – Jan 2017 • 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. ### Staff Quality and Technical Lead @ Illumina Jan 2011 – Jan 2016 | Hayward • 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. ### Staff Quality and Project Leader @ Gilead Sciences Jan 2007 – Jan 2011 | Foster City • Directed the development, deployment, and implementation of Global Quality Systems across all manufacturing and research facilities, providing strategic and technical leadership to ensure seamless integration and compliance. • Enhanced the Customer Complaints process and CAPA system, achieving a 98% customer satisfaction rating by streamlining workflows and optimizing issue resolution protocols. • Led the establishment of a Customer Call Center, managing a $1.8M budget and successfully integrating operations with the SAP system to improve service efficiency. Optimized the Annual Product Quality Review (APQR) process, improving data collection capabilities to proactively identify adverse trends across the commercial product platform. Reduced report cycle times, enabling resource reallocation and enhancing overall productivity. ### QA Manager @ Life Technologies Jan 2003 – Jan 2007 | Foster City • Provided Quality Assurance support for the commercial launch of new IVD products and assays by actively participating in cross-functional project teams for new product introductions. • Streamlined the Product Commercialization Process (PCP), reducing development cycle time by 65%. Played a key leadership role in introducing agile and iterative development methodologies into the PCP framework. • Designed and implemented Field Problem Reporting and Escalation databases, increasing customer satisfaction ratings to 96% by enhancing issue tracking and resolution processes. • Led the validation of Commercial Off-The-Shelf (COTS) software and served as a subject matter expert, guiding project teams on software validation requirements. • Implemented robust CAPA and Customer Complaint processes, improving the organization's ability to identify and address systemic quality issues. • Accelerated time-to-market for IVD products, providing strategic leadership to cross-functional teams transitioning products from Research Use Only (RUO) to the clinical market. • Acted as a liaison with regulatory authorities such as UL, CSA, and FDA, coordinating audits, meetings, and conferences to ensure compliance with applicable regulations. ### Senior Software Engineer and Business Analyst - US @ Macro4 Inc Jan 2001 – Jan 2002 • Responsible for providing Technical Asisstance to Macro4 Sales Executives in the design and implementation of the company solutions to the highest level of customer satisfaction. •Prepared project proposals, developed project schedules, produced and maintained accurate project plans according to the company methodology. Managed operational tasks for existing systems. SAP integration and validation (HR module, Finance module and Output management). •Developed integration solutions for multi channel delivery and document workflow ### Project Manager - UK @ Macro4 Inc Jan 1997 – Jan 2001 • Prepared comprehensive project proposals and developed detailed project schedules, ensuring alignment with company methodologies. Maintained accurate and up-to-date project plans to drive successful execution. • Managed operational tasks for existing systems, including SAP integration and validation across HR, Finance, and Output Management modules. • Led projects involving CRM and Enterprise Content Management solutions, integrating these systems with SAP, Siebel, and IBM-compatible mainframe databases. • Received multiple local awards for innovative technical solutions and cost-effective architectural designs, showcasing technical creativity and strategic problem-solving skills. ### Mission to Romania @ Volunteering Jan 1999 – Jan 2000 | Romania ### Solution Architect @ MDL Information Systems, UK Jan 1992 – Jan 1997 • Developed strategic business requirements by leveraging industry standards, SDLC methodologies, and advanced toolsets to create an efficient software development strategy. • Applied data and process modeling techniques alongside workflow analysis to optimize software development processes and align with organizational goals. • Led embedded software verification and validation efforts, including test development, automation, and adherence to technical standards. Conducted hazard and risk analysis to ensure compliance with product regulatory requirements and maintained alignment with relevant regulatory agencies. ## Education ### Masters in Analytical Chemistry University of Bucharest ### Higher National Diploma (BcS) in Computing Basingstoke College of Technology ### College in Mathematics and Physics Mircea cel Batrin National College ### Genetic Engineering and Molecular Biology Oxford Lifelong Learning, University of Oxford ## Contact & Social - LinkedIn: https://linkedin.com/in/1698907543bbc --- Source: https://flows.cv/brindusa JSON Resume: https://flows.cv/brindusa/resume.json Last updated: 2026-04-13