Kailani Montane

About Kailani Montane

Project Director and Executive Leadership Team Member with 7+ years leading end-to-end medical device development from concept through FDA clearance and commercialization. Expert in managing complex, multi-stakeholder projects ranging from $50k-$1M budgets while ensuring regulatory compliance across Class I & II devices. Proven ability to orchestrate cross-functional teams, optimize contract manufacturing relationships, and drive strategic initiatives that accelerate product launches and operational efficiency in fast-paced medical device environments.

Experience

1. Project Director

   Biorep Technologies, Inc

   Feb 2023 — Present

   Serve on 5-member executive leadership team driving strategic planning and organizational alignment across 23-person medical device company-Manage company-wide projects ($50K-$1M budgets) across 4-8+ concurrent initiatives while maintaining 90%+ budget adherence and FDA/ISO compliance-Track department KPIs and project metrics, providing executive visibility into program status, risks, and budget performance-Lead full product development lifecycle for Class I & II devices, managing design reviews, V&V activities, and design transfer with 100% FDA 21 CFR 820 and ISO 13485 compliance-Develop comprehensive project plans managing dependencies, critical paths, and risk mitigation across concurrent initiatives-Serve as primary client liaison, managing expectations and ensuring customer satisfaction through proactive communication-Established enterprise-wide PM framework including templates and design review protocols, accelerating validation and improving cross-functional collaboration-Execute technical review of 5-10 weekly Change Controls, assessing design modifications for functional impact and regulatory compliance-Conduct ISO 13485/FDA QSR internal audits, identifying nonconformances and driving CAPA implementation-Direct CAPA lifecycle management, leading root cause analysis and overseeing 10-20 concurrent CAPAs with 90% on-time closure-Manage supplier qualification program for 100+ suppliers, implementing corrective actions to maintain quality standards

Education

• Duke University

  Bachelor of Science, Biomedical Engineering, Medical Devices

  2013 — 2017

• Miami Lakes Educational Center

  Cambridge Advanced International Certificate of Education (AICE) Diploma, Engineering Strand

  2009 — 2013

Skills

• Fda Testing
• Engineering
• Seapine Test Track Pro
• 3d Prototyping
• Teamwork
• Research
• Piano
• Milling
• Public Speaking
• Verification and Validation (V&V)
• Product Design
• Biomedical Engineering
• Leadership
• Research and Development (R&D)
• Matlab
• Medical Devices
• Entrepreneurship
• Microsoft Office
• Microsoft Word
• Team Leadership
• Solidworks
• Design Control
• 3d Printing
• Mastercam
• Microsoft Powerpoint
• Karate
• Design Verification Testing
• Microsoft Excel
• Soldering