Mike Bruhns

About Mike Bruhns

Highly dynamic, results-oriented Business, Account Management, Operations, Manufacturing, Quality & Sourcing Leader, with a passion for driving organizational and business success through extensive international business experience, proven cross-functional collaboration, an unrelenting drive for continuous improvement and a hands-on, high-energy, think out-of-the-box personality. Extensive experience in driving positive change in the Clinical Trials, Clinical Research, Connected Devices, Lighting, Semiconductor, Pharmaceutical, Automotive and industrial automation industries, due to diversified, successful careers in business development, account management, operations, quality, supply chain, strategic sourcing, customer service, applications engineering, reliability and manufacturing engineering. Extensive international business experience gained through driving global manufacturing, supplier development, contract manufacturing, applications support and customer satisfaction in support of exponential growth in various highly technical and culturally diversified industries.Clinical Trials | Connected Devices in Clinical Research | Global Medical Regulatory Compliance | Global Logistics | Account Management | Business Development | Quality Management Systems (ISO9001, ISO/TS16949)| Strategic Sourcing | Global Commodity Management | Global Operations | Supplier Development | Business Intelligence | Continuous Improvement | LEAN / Six Sigma | Process Development | Product Reliability | Design Robustness/ Design Verification | Systems and Process Controls | New Product Development | Customer Support & Satisfaction | Customer Complaint Management/ RMA | Organizational Development | International Business | Global Contract Manufacturing | ODM & OEM Global Sourcing | SPC & Analytical Improvement | ERP & MRP Implementation | APQP (PPAP, FMEA, Control Plans, etc.)| Agile | Software Development Life Cycle (SLDC)| 21CFR | GMP / GxP

Experience

1. Sr Director, Device Strategy, Commercial Lead, Vendor Partnerships and Logistics, Connected Devices

   IQVIA

   Mar 2019 — Present

   Led transformative change in clinical research through successful development and implementation of vendor and device strategy for Connected Devices in global clinical trials- Developed, expanded connected devices acceptance, inclusion and optimization within global phase 1-4 clinical trials- Successful business results in RFI, RFP, BDM for both large pharma and emerging biotech companies supporting clinical research globally- Developed, maintained and matured vendor partnerships, enabling exponential growth in connected devices across all therapeutic areas and service lines- Leadership in growing sponsor relationships, through key account business development activities, governance and operational performance- Developed pricing strategy for connected devices business- Led global logistics organization in ensuring market leadership in device regulatory compliance and geographic presence for seamless device provisioning throughout the globe- Horizon scanning and vetting of new technologies for inclusion in industry leading connected devices portfolio, ensuring optimal device selection across all clinical research service lines and therapeutic areas- Led vendor/ device onboarding efforts, including risk-based assessments, financial system setup and contracting- Led vendor contracting efforts, including study level work orders, global MSAs, SLAs- Developed effective vendor governance structure, ensuring optimized operational performance and continuous improvement in critical supply chain - Commodity management for medical data devices (class 1-3)- Extensive knowledge of device technology in Continuous Glucose Monitoring, Blood Glucose Monitoring, Cardiac Safety (12-lead, 1-6 lead ECG), Spirometry, Vital Sign Monitoring, Medication Adherence, Actigraphy, Digital Biomarkers and AI

Education

• Rutgers University

  Bachelor of Science (BS) Industrial Engineering

Skills

• Engineering
• Lean Manufacturing
• Fmea
• Failure Mode and Effects Analysis (Fmea)
• Process Improvement
• Design of Experiments
• Manufacturing
• Six Sigma
• Continuous Improvement
• Strategic Supplier Development
• Quality Management
• Engineering Management
• Process Engineering
• Business Analysis
• Team Management
• Electronics
• Supply Chain Management
• Failure Analysis
• Supplier Quality Engineering
• Cross-Functional Team Leadership
• Supplier Quality
• Semiconductors
• Liasoning
• Leadership
• Product Development
• Production Process Development
• Management
• Statistical Process Control (Spc)
• Spc