Experience

Kneat Solutions

• Ireland
• Software Development
• 200 - 300 Employee

• Project Manager

  • Jun 2023 - Present



Cytiva

• Biotechnology Research
• 700 & Above Employee

• Project Engineer

  • Nov 2021 - Oct 2022

  ● Leading projects to supply a worldwide customer base with advanced aseptic processing systems. ● Developing, defining, and reviewing project specifications. ● Creation of the system turn-over package (TOP); maintaining project communication documents and schedule. ● Coordinating and connecting with the customer on a regular basis to ensure customer requirements are clear and manufacturing requirements are met. ● Designing and executing FAT, SAT, and IQ/OQ protocols to ensure that requirements are met; resolving discrepancies in a timely manner Show less



Rostrum Medical Innovations Inc.

• Canada
• Medical Device
• 1 - 100 Employee

• Systems Engineer

  • Sep 2021 - Jan 2022

  ● Translating stakeholder requirements, market needs into engineering requirements. ● Managing technical and functional risk analysis (FMEA) to uncover engineering and product risks. ● Performing usability and hazard analysis. ● Managing traceability for the system design effort and producing a traceability report. ● Organizing design reviews. Participating in review; resolving technical issues; root cause analysis. ● Translating stakeholder requirements, market needs into engineering requirements. ● Managing technical and functional risk analysis (FMEA) to uncover engineering and product risks. ● Performing usability and hazard analysis. ● Managing traceability for the system design effort and producing a traceability report. ● Organizing design reviews. Participating in review; resolving technical issues; root cause analysis.



Evasc Neurovascular

• Canada
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Senior Engineer

  • Jan 2021 - Jul 2021

• Project Engineer

  • May 2017 - Dec 2020

  At Evasc I led multiple projects of varying scale and complexity including:1. The development of a new delivery system for the second-generation of the company’s flagship product - eCLIPs™ Bifurcation System (for commercial distribution in EU)2. Expanding the size matrix of the eCLIPs™ Bifurcation System product (for commercial distribution in EU)3. Manufacturing Process Validation (IQ, OQ, PQ) of new processes and re-validation of legacy processesMy responsibilities at Evasc included:● Developing comprehensive project plans, preparation of budgets, developing project risk management plans● Tracking projects through execution – managing costs, reporting project performance to management, implementing risk responses● Leading projects through the entire product development cycle from concept generation to CE marking● Gathering clinical/user needs, determining product requirements and developing technical specifications● Concept generation, prototype design and preparation of drawings and specifications● Product testing and evaluation, completion of test reports to support design selection – test method validation, design verification and validation● Leading and participating in design reviews● Identifying and mitigating technological risks throughout design and manufacture – dFMEA, pFMEA, uFMEA● Sourcing vendors for outsourced parts and processes - vendor qualification.● Development of manufacturing processes - writing SOPs and QC inspection procedures, design of jigs/tools/fixtures, specifying equipment requirements (URS), process validation (IQ, OQ, PQ)● Managing transfer to production activities in a timely effective manner.● Development of the Design History File● Managing the training of manufacturing personnel● Implementing improvement initiatives – Lean Six Sigma Show less



Alcon

• Switzerland
• Medical Equipment Manufacturing
• 700 & Above Employee

• Project Engineer

  • Feb 2016 - May 2017

  ● Developing a comprehensive project plan, managing the project schedule, and tracking spending ● Developing User Requirement Specifications ● Leading system risk analysis activities ● Working with vendors to procure custom manufacturing equipment ● Scheduling install and commissioning of new equipment ● Designing and executing validation studies – IQ, OQ, PQ ● Developing a comprehensive project plan, managing the project schedule, and tracking spending ● Developing User Requirement Specifications ● Leading system risk analysis activities ● Working with vendors to procure custom manufacturing equipment ● Scheduling install and commissioning of new equipment ● Designing and executing validation studies – IQ, OQ, PQ



Boston Scientific

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Process Development Engineer

  • May 2015 - Feb 2016

  • Co-ordinated pilot line builds – managed work orders and trained operators • Executed DOE test plans and reported on data • Maintained the validated status of pilot line equipment – arranged calibrations and executed equipment qualification (IQ, OQ) protocols • Co-ordinated pilot line builds – managed work orders and trained operators • Executed DOE test plans and reported on data • Maintained the validated status of pilot line equipment – arranged calibrations and executed equipment qualification (IQ, OQ) protocols



Musgrave

• Ireland
• Retail
• 700 & Above Employee

• General Assistant

  • May 2011 - Sep 2014

  • Checkout Operations • Stock merchandising • Customer Service • Checkout Operations • Stock merchandising • Customer Service



Dell EMC

• United States
• IT Services and IT Consulting
• 700 & Above Employee

• Test Equipment Engineer

  • Mar 2013 - Sep 2013

  • Implementation of process improvement projects • Inventory management and spend tracking • Completed Lean Six Sigma Yellow Belt • Implementation of process improvement projects • Inventory management and spend tracking • Completed Lean Six Sigma Yellow Belt