Summary
Overview
Work History
Education
Skills
Certification
Timeline
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Tim Irle

Software Quality Engineer
Arvada

Summary

Passionate Quality Engineer actively pursuing a Software Quality Engineer role to add immediate value to your team. Bringing in-depth new product development, design controls, risk management, CAPA investigations and Lean Six Sigma experience in Quality System maintenance to ensure your team reliably and repeatedly delivers a high level of product quality to its customers and better serves the healthcare community.

Overview

9
9
years of professional experience
1
1
Certification

Work History

Senior Software Quality Engineer

Medtronic | Entegee
06.2024 - Current

Software Quality Analyst

Terumo BCT
08.2022 - 04.2024
  • Followed Design Controls through designing Verification protocols of design outputs
  • Planned and executed manual test cases against newly implemented features and software bugs
  • Performed system integration testing and system of systems integration testing
  • Troubleshooted, debugged and performed risk analysis on existing software

Software Systems Engineer, Product Owner

Terumo BCT
08.2021 - 08.2022
  • Followed Design Controls by deriving user requirements for both medical devices and associated software
  • Managed Defects and Risk by identifying hazards and developing mitigations as part of a cross-functional team on the Software Review Board.
  • Worked with Scrum Teams in an Agile environment to plan and implement stories from the backlog into working, deliverable software
  • Defined the Acceptance Criteria for stories and determined if they were met by the implementation

Quality Engineer

Intertech Plastics
05.2020 - 01.2021
  • New Product Introduction for FDA packaging, commercial and ITAR accounts via PPAP Stage Gates
  • Executed Process Validation plans (IQ OQ PQ)
  • Risk Management for new products through Failure Mode & Effects Analysis
  • Maintained product integrity through Statistical Process Control and other Lean Six Sigma tools
  • Managed Defects through Pareto Analysis
  • Edited and updated Quality Plans

Quality Engineer

Tenere
11.2019 - 05.2020
  • Collaborated with cross-functional teams to continuously improve processes through CAPAs
  • Managed Defects through Pareto Analysis and the application of other Lean Six Sigma tools
  • Additionally Managed Defects through the Material Review process for all nonconforming products
  • Performed Process Validation of new parts for medical accounts via First Article Inspections and Process Capability Analysis

Quality Engineer

3D Systems
05.2019 - 11.2019
  • Leveraged CAPAs to improve medical devices, manufacturing processes, and an ISO 13485 QMS
  • Documented and resolved customer complaints through Root Cause Analysis
  • Tracked and escalated customer complaint trends
  • QC inspection of medical devices and technical review of the Device History Record
  • Drafted SOPs and Work Instructions

Biomedical Engineer

3D Systems
05.2017 - 05.2019
  • Consulted with top surgeons in their field to develop custom Virtual Surgical Plans for individual patients
  • Technical design of medical devices through CAD-based engineering of patient-specific 3D files
  • Managed multiple concurrent projects and coordinated with cross-functional teams
  • Final review of product design and function
  • Over 300 cases with 0 missed surgeries and 0 injuries
  • Validation testing for new software development

Biomedical Sales Engineer

ADInstruments
10.2016 - 04.2017
  • Strategically sold biomedical lab instruments and software to neurologists and biologists
  • Exceeded performance goals, Q2 2016 (113%)

Education

Bachelor of Science - Biomedical Engineering

Illinois Institute of Technology
Chicago, IL
05.2001 -

Skills

  • ISO 13485
  • New Product Development
  • Software Test Engineering
  • Verification and Validation
  • Design Controls
  • Risk Management
  • FMEAs
  • Statistical Process Control
  • Quality Plans
  • CAPA Investigations
  • Root Cause Analysis
  • First Article Inspections
  • Process Capability Analysis
  • Complaint Handling and Trending
  • DHR Review
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Certification

Lean Six Sigma Green Belt, CSSC

Timeline

Senior Software Quality Engineer

Medtronic | Entegee
06.2024 - Current

Software Quality Analyst

Terumo BCT
08.2022 - 04.2024

Software Systems Engineer, Product Owner

Terumo BCT
08.2021 - 08.2022

Quality Engineer

Intertech Plastics
05.2020 - 01.2021

Quality Engineer

Tenere
11.2019 - 05.2020

Quality Engineer

3D Systems
05.2019 - 11.2019

Biomedical Engineer

3D Systems
05.2017 - 05.2019

Biomedical Sales Engineer

ADInstruments
10.2016 - 04.2017

Bachelor of Science - Biomedical Engineering

Illinois Institute of Technology
05.2001 -

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Tim IrleSoftware Quality Engineer