Hi, I’m Savvas

Welcome to my website.

Savvas Voulgaris photo

Senior Mechanical Design Engineer

Specialized in Electro-Mechanical Medical Devices, with 7 years of work experience.
Speaking Greek (native), English (fluent) and Japanese (basic).

Professional Experience

Olympus Keymed logo
5/2017 – present

OLYMPUS KEYMED LTD (UK)

Senior Mechanical Engineer

Lead Mechanical Engineer for Class I Medical Device

  • Concept Development & Convergence Analysis
  • Detailed Design for Plastic and Sheet Metal components
  • Design Verification & Validation/ Reprocessing Validation as per IEC 60601-1 & IEC 62366-1
  • FEA Structural and Thermal analysis (Solidworks Professional)
  • Technical Drawings Approval (Plastic / Metal Components Design) as per BS 8888
  • Create and Maintain complete DHF file (Design Inputs/ Outputs, Risk Management) as per ISO 13485

Mechanical Engineer for Class IIa Electrical Medical Device – In progress

  • Prototype development and Testing for Plastic (injection Molding) and Sheet metal components
  • Design Verification and Reprocessing Validation as per IEC 60601-1 & BS EN ISO 10993-1
  • Structural & Thermal FEA and Data Statistical Analysis (Minitab & Comsol)
  • Contribute Technical and Regulatory Documentation for MDD/ MDR and FDA 510(k) submission as per ISO 13485 & FDA 21 CFR Part 801
  • Detailed Design for Plastic and Metal components
  • Mechanics and Electronics integration for electric motor control
nemaura pharma logo
8/2015 – 4/2017

NEMAURA PHARMA (UK)

Design Engineer

Design and development of 2x Class II Medical devices

  • Conceptual development, prototyping and assembling of a Class II medical devices
  • CAD modelling and detailed Design for Plastic Components (Solidworks)
  • Design verification and validation ensuring compliance to ISO 11608-1 & ISO 7864
  • Contributed and updated procedures for Quality Management System
  • Participate in progressing of Risk Management File, Device History File, Device Master Records and Device History Records documentation through a Notified Body review as per ISO 13485
  • Liaise with manufacturers and suppliers for parts manufacturing and purchasing
  • Rotary Insulin Injector Device | US20180369552A
Mitras Architectural Metalwork logo
3/2014 – 8/2014

MITRAS ARCHITECTURAL METALWORK (GR)

Design Engineer

  • Conceptual and technical design of custom steel, architectural structures
  • CAD modeling using Solidworks
  • Creation of project technical specification, cost estimation and detailed drawing proposals
  • Create shop technical drawings for manufacturing, assembly and welding
  • Liaise with customers and suppliers
  • Installation of assembled structures on site
Attiki Gas Supply logo
10/2011 – 4/2012

ATTIKA GAS SUPPLY (GR)

Mechanical Engineer (internship)

  • Network and site installations mapping
  • Building of technical plans, 2D drawings, P&IDs and maps
  • CAD modelling using Autocad

Expertise & Skills

Engineering Simulation

  • Linear/ Non-Linear, Static/ Transient, Fatigue, Buckling Analysis
  • Heat transfer in solids, Electronic enclosures cooling, Thermal/ CFD Analysis
  • 2-way coupled Fluid Structural Interaction

Software:

Statistical Analysis

  • Variable Data Tolerance Intervals
  • Reliability Analysis
  • DOE 2-Level & Full Factorial Design
  • 2-sample T Tests
  • Mixed Effects ANOVA
  • Process Capability

Standards Knowledge

ISO 13485
IEC 60601-1
ISO 14971
BS 8888
ISO 11608-1

ISO 7864
FDA 21 CFR P. 801
EN ISO 10993-1
BS EN 62366-1
ASME V&V10

Design

  • Plastic Components Design, Injection Molding
  • Sheet Metal Design
  • Tolerance Analysis, Worst RSS, GD&T
  • 3D Printing

Software:

Education & Training

2008 – 2012

Mechanical Engineering (B.Eng)

Graduated 2:1 – Full Time Course
Major Project: Design and Development of a Valveless Pulsejet Engine
Technological Educational Institute (TEI) of Chalkida, Greece

2008 – 2012
2014 – 2015

Design Engineering (M.Sc)

Graduated 2:1 – Full Time Course
Major Project: Evaluation of Motorcycling Body Armour
Loughborough University UK

2014 – 2015
10/2015

Good manufacturing practices

Inspired Pharma Training

10/2015
2016

Statistical Process Control

Bywater EXCEL

2016
10/2018

Biocombatibility

Olympus E-Learning

10/2018
2019/2020

Statistical Analysis

Statistical Tools for Medical Devices
Introduction & Advanced Reliability
MINITAB

2019/2020
2020

Engineering Simulation

Verification and Validation in Engineering Simulation
NAFEMS

Practical Modelling of Joints & Connections
NAFEMS

2020
2020

Reprocessing for Medical Devices

Nelson Labs

2020

Contact

For a detailed CV and/or project & product portfolio
please feel free to contact me.

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