Raiem Smith

About Raiem Smith

I am a hard-working, motivated, inquisitive, and selfless individual that strives for the best from myself and those around me. Experienced engineer with a background in medical device product development, including: Medical Device design experience, including design selection, prototyping, testing, verification, and validation. Experience working on a cross-functional team across multiple organizational groups. Experience in designing and conducting engineering tests requiring DoE and statistical testing. Experience in device design and complaint investigations. Experience with Design Controls and relevant medical device ISO Standards Experience interfacing with Physicians/Clinical Support personnel to determine and assess User Needs Experience with SolidWorks (CAD), Minitab, and Microsoft Office. Completed Six-Sigma Green Belt training

Experience

1. Engineer Iv, Device Development

   Alexion Pharmaceuticals, Inc.

   Jan 2025 — Present · Boston, MA, US

   Drive/support device development activities with the Device Core Team to development and bring to market combination product.• Manage timeline for development as well as life cycle management for combination products.• Work with device partners in the creation, evolution, optimization and verification of designs and hardware for drug delivery devices.• Evaluate device design, function, assembly, manufacturability, and support verification/validation of drug delivery combination products.• Lead the Design Control Activities including documentation, sample preparation and defining with the lab the appropriate testing method/equipment.• Drive and facilitate team exercise on risk analysis, evaluation, and control as well as all compile risk management documentation.• Help assess and develop innovative container closure systems.• Conduct characterization for device function, assembly, manufacturability, etc. using both CAE and engineering techniques such as 1st principal modeling, DOE, FEA.• Understand process development and key process parameter identification, specification definition.• Consult with third parties such as specialist manufacturers and toolmakers.• Communicate effectively, both verbally and in writing, internally across departments and with external suppliers.• Comply with the Company’s quality assurance requirements as well as applicable regulatory requirements.

Education

• University of Rochester

  Master of Science - MS, Biomedical Engineering

  2017 — 2018

• University of Rochester

  Bachelor of Science - BS, Biomedical Engineering

  2013 — 2017

Skills

• Gmp
• Computer-Aided Design (Cad)
• Medical Device Design
• Design of Experiments
• Powerpoint
• Microsoft Excel
• Creo Parametric
• Failure Mode and Effects Analysis (Fmea)
• Biomechanics
• Organization Skills
• Matlab
• Medical Devices
• Windows
• Computer Proficiency
• Design Failure Mode and Effect Analysis (Dfmea)
• Ptc Creo
• Microsoft Office
• Iso Standards
• Iso 13485
• Email
• Public Speaking
• Iso 14971
• Help Desk Support
• Customer Service
• Iso 10993
• Corrective and Preventive Action (Capa)
• Troubleshooting
• Microsoft Word
• Leadership
• Simple Lab Experience
• Hazard Analysis