Luke Amory

About Luke Amory

Experienced Project Manager and Product Engineer with a demonstrated history of working in the medical device industry. Skilled in Project Management(PMP certified), Verification and Validation (V&V), Root Cause Analysis, Risk Management, Process Qualification, and Materials. Strong engineering professional with a Bachelor of Science (BS) focused in Biomedical/Medical Engineering from Penn State University. Currently enrolled in Lehigh University\'s Flex MBA program.

Experience

1. Manager, R & d Product Development

   B. Braun Medical Inc. (US)

   May 2024 — Present · Allentown, PA, US

   Leadership & Oversight: Manage a team of product development engineers and project managers in the design and development of innovative medical devices, ensuring compliance with FDA 21 CFR 820 regulations.• Mentorship & Development: Provide guidance and coaching to foster the team\'s professional growth and enhance their understanding of industry standards and best practices.• Talent Acquisition & Succession Planning: Develop and implement effective recruitment strategies to attract top talent and ensure robust succession planning.• Collaboration & Coordination: Work closely with other managers and subject matter experts to identify and eliminate obstacles, facilitating smooth project progression.• Audit Expertise: Act as the primary point of contact and subject matter expert (SME) for audits, ensuring thorough preparation and compliance.

Education

• Penn State University

  Bachelor of Science (BS), Biomedical/Medical Engineering

  2012 — 2016

• Lehigh University

  Master of Business Administration - MBA

Skills

• Data Analysis
• Microsoft Word
• Microsoft Office
• Solidworks
• Risk Analysis
• Catia
• Research
• Materials
• Patent Searching
• Process Qualification
• Design
• Process Validation
• Laboratory Techniques
• Comsol
• Microsoft Excel
• Powerpoint
• Matlab
• Clinical Research
• Design for Manufacturing
• R&D
• Functional Testing