Saeid Ebrahim

Quality Engineer

Saeid has vast experience in high volume production industries and a thorough knowledge of product and process validation. Recently he obtained his ASQ-CQE recognition indicating a proficiency in and a comprehension of quality engineering principles and practices. Saeid has been involved in a number of projects as Validation Engineer, Development Engineer, Test Engineer and Project Manager.

 

EXPERIENCE…
  • Developed and executed Variable Test Method Validation Protocol and wrote the final report for an Optical Blood Detector (R&R Gauge Study).
  • Developed and executed Process Characterization Protocol for wettability process of parts made of polymer using Design of Experiment, analyzing the statistical data using Minitab and finally wrote the final report.
  • Executed Process Characterization Protocols for A-271 Armstrong Bonding, UV Loctice Bonding and Hysol Bonding of various parts using Design of Experiment, analyzing the data using Minitab and finally writing the final report for these protocols.
  • Developed and executed OQ, PQ, and PPQ Protocols for leading Class III device manufacturer. Analyzed variable raw data using six sigma methodology to ensure results achieved process and product requirements.
  • Developed SOP’s, protocols and executed Attribute & Variable Test Method Validation (R&R Gauge Study using Minitab) Protocols including performance of statistical data analysis and finally wrote the final report.
  • Participated in development of Master Validation Plan for several Class III medical device product families.
  • Reviewed and revised the existing pFMEA. for a Class III medical device
  • Enhanced manufacturing processes through identification and remediation of process and product non-conformism.
  • Project manager responsible for training group in statistics, statistical tools (Minitab), and statistical analysis of variable data.
  • Participated in both internal, third party and FDA audits to answer the technical and quality related questions about the validation processes.
  • Performed Quality System Audit and Gap Analysis of Refurbishment Process of Enriched Oxygen Cylinder Valve for compliance with GMPs.
  • Revised the process for Cleaning and assembly of an Enriched Oxygen Cylinder Combination Valve from GMP Standpoint. Responsibilities included development and implementation of Quality System including, documentation of Work Instructions, SOP’s, FMEA, Flow Chart, Test Method Validation, and Cleaning Validation.
  • Hands-on and managerial experience executing machine development projects.
  • Managed and executed validation projects at design level and prototype testing level.
  • Managed a consultant engineering team to develop a Test Tool System (H/W) for base station of mobile system. Developed educational material for personnel training focused on test tooling.
  • Initiated and directed engineering team to start and run a $1.4 M high risk machining project.
  • Developed and designed prototype machine.
  • Designed and fabricated a test rig to perform test to develop new machine.
  • Participated in development of products as CFD Engineer. Ran production computer models to provide the technical data for design of the Electro Magnetic product and the system. Developed 3-D CFD (computational Fluid dynamic) & MHD (Magnet Hydrodynamic) computer models.
POSITIONS HELD…
  • Quality Engineer – BioTeknica, Inc.
  • Senior Project Manager – SAAB Automobile
  • Consultant Project Manager – AF-System Design
  • Project Manager – Asea Brown Boweri
  • Product Development Engineer – Asea Brown Boweri
  • CFD Engineer & Test Engineer – Asea Brown Boweri
EDUCATION…
  • MSc., Mechanical Engineering – Chalmers University of Technology (Sweden)
CONTINUING EDUCATION…
  • STAT101 and 201 Taylor Enterprises, Inc (2008).
  • DOE 101 and 201 Taylor Enterprises, Inc (2008).
  • ASQ-CQE (2007)
  • Process validation, Normality assessment, Sampling Plan (2006)
  • Project Management 1 & 2 ABB Business Academy (2000).
  • Advanced courses in Fluid Dynamic 16 university p. (1999)