Mack Houdek Email & Phone Number

Burlington, Massachusetts, United States

Burlington, Massachusetts, United States

Burlington, Massachusetts, United States

Spencer, Indiana, United States

- Managed Design History Files (DHFs) of a $100M+ per annum portfolio of medical devices-Identified user needs, developed into design input requirements, performed risk analysis, verification and validation testing-Proposed and implemented innovative and effective design and process solutions to improve device safety and performance-Led team of 3 engineers in remediating 21 DHFs to achieve EU MDR compliance and avoid market gaps-Drove CAPA investigations and Root-Cause Analysis stemming from internal audits and post market data-Evaluated effectiveness of material and supplier changes in meeting design requirements and user needs

Bloomington, Indiana, United States

- Sustaining and technical lead over three EU MDR remediation projects for urological medical devices- Identified and closed testing gaps, created DIRs, and developed V&V test methods to maintain State of the Art- Theorized, authored, and validated over half a dozen novel test methods for devices without ISO standards- Organized and communicated with a diverse cross-functional team to meet company goals and regulatory deadlines

Huntington, Indiana, United States

- Proposed new product development projects bringing innovative solutions to complex engineering problems- Created and executed verification and validation testing to evaluate fulfillment of design inputs- Modeled prototype devices in SolidWorks, built evidence for FDA 510K submission claims- Reviewed medical device implant and instrument prints for adherence to GD&T guidelines

Warsaw, Indiana, United States

- Drafted new EU MDR Compliant IFUs for Zimmer Biomet trauma implants- Evaluated the need for new FDA 510K submissions due to design or documentation updates- Assessed regulatory impact of changes worldwide, evaluating the need for new submissions in select markets- Promoted to IFU/Labeling team lead, tasked with tracking and communicating team progress to RA Manager

Melbourne, Florida, United States