Parisa Pouyan

• Led multiple supplier-driven component changes, ensuring design modifications maintained device performance and safety. Conducted bench testing, regulatory testing, and engineering analysis for changes such as 80369 compliance.
• Played a key role in an ongoing project aimed at achieving $700,000 in cost savings by reducing human visual inspections in WATCHMAN manufacturing. The project successfully achieved a 42% reduction in scrap through design and process control modifications. The team’s exceptional performance was recognized with a VIP award.
• Applied FMEA and risk management methodologies to assess risks and design changes, ensuring compliance with FDA, EU-MDR, and other global regulatory standards.
• Performed fatigue analysis using FEA on several defects, leveraging Nitinol material knowledge to assess performance cliffs and optimize specifications.
• Led human factors engineering efforts, ensuring product usability and safety through formative and summative evaluations in real-world settings.
• Developed technical reports, risk assessments, validation protocols, and testing documentation to support regulatory submissions for EU-MDR and China national standards.

• Directed R&D activities supporting EU-MDR submissions for IC/PI products, including leading cross-functional teams for scrap reduction, manufacturing improvements, and supplier capability changes.
• Developed and implemented design changes based on human factors analysis, contributing to improved product usability and performance.
• Conducted material gap analyses for multiple IC/PI products and created technical reports in compliance with global regulatory standards (RoHS, EU-MDR).
• Worked closely with regulatory and design assurance teams to develop risk assessments, validation protocols, and use-related risk analyses.

• Developed and executed protocols for qualification, validation, and verification of manufacturing processes. Utilized FMEA as a risk assessment tool and performed statistical analysis to evaluate process reliability and identify opportunities for defect reduction.
• Trained technicians and operators on process improvements, developed work instructions, and ensured successful implementation of design and process changes.
• Identified opportunities for equipment upgrades and process improvements, leading to increased efficiency and reduced manufacturing costs

• Collaborated with risk assessment engineers to analyze operation and failure data, contributing to the development of maintenance plans to improve equipment reliability and reduce costs.
• Managed action requests and corrective actions to address equipment design discrepancies and ensure compliance with safety regulations.
• Participated in leak detection testing during plant refueling outages, contributing to regulatory compliance and equipment reliability.

Assisted with design review for the Fukushima FLEX project, implementing mitigation strategies for beyond-design-basis accidents and ensuring compliance with regulatory requirements.