Hi, I’m Savvas

Welcome to my website.

Savvas Voulgaris photo

Senior Mechanical Design Engineer

Specialized in Electro-Mechanical Medical Device Development, with 9.5 years of work experience.

Speaking Greek (native), English (fluent) and Japanese (basic).

Currently based in Cambridge, UK.

Professional Experience

Sagentia Innovation Cambridge logo

SAGENTIA INNOVATION (UK)

Mechanical Engineer Consultant

Olympus Keymed logo

OLYMPUS KEYMED LTD (UK)

Senior Mechanical Engineer

Mechanical Engineer for Class IIa Electrical Medical Device

  • 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

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
nemaura pharma logo

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

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

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
7/2023

Data-Driven Project Management: Project Metrics That Matter

LinkedIn

7/2023
7/2023

Project Management Foundations

LinkedIn

7/2023
7/2023

Project Management Foundations: Schedules

LinkedIn

7/2023

Contact

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

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