Melinda McElwain

About Melinda McElwain

Certified Project Management Professional (PMP) • Certified Six Sigma Green Belt (CSSGB)• Certified DiSC Facilitator• 8+ years Program and Project Management• 9+ years People Management• 7+ years cGMP, ISO, FDA, and EU Regulated Environment Experience• 8+ years of Process Excellence Management• Proficient in: PowerPoint, Word, Excel, Project, SharePoint, Kronos, Asana, Agile and OracleRecent Projects-EU Medical Device Regulation (EU 2017/745): Review of all products in portfolio to meet upcoming EU MDR requirements. Included development of a reverse engineering remediation process to ensure documentation is state of the art for identified products. Areas of remediation comprised risk management (per ISO 14971), clinical evaluation, design controls (including FDA 21 CFR 820), Design History File assembly and remediation (per FDA 21 CFR 820), labeling, design verification and validation, biocompatibility (per ISO 10993), packaging validation, regulatory and post market surveillance. Led seven cross functional teams through the remediation process for MDD Class IIa and IIb devices while building the global process for MDR remediation process-Continuous improvement projects utilizing Lean Six Sigma methodology for quality operations, regulatory and quality systems-Quality and Regulatory Program Management: Support for drug/device combination products and customer in the areas of quality improvement, change management, regulatory submissions, regulatory compliance, SCAR and CAPA ownership-Global PMO Process Excellence: Support in developing, implementing, and training on PM methodology including processes, tools and templates to provide guidance and support to the global PMO-Development of an internet-based global university for internal and external stakeholders including systems and user interface, external customer programs and FDA 21 CFR Part 11 compliant quality management training system.

Experience

1. Senior Program Manager

   Boston Scientific

   Aug 2025 — Present

   Lead NPD and Acquisition project and programs within IO & E division.

Education

• University of Minnesota

  Bachelor of Science, Microbiology

  2006 — 2011

• Macquarie University - Australia

  Internship, Marine Biology

  2010 — 2010

• University of Arizona

  Master of Business Administration - MBA, Project Management

  2018 — 2020

• Andover High School

  High School Diploma

  2002 — 2006