Employment Opportunity

Senior Process Development Engineer

Job Description Overview

This job description sets out to define the job role of a Senior Process Development Engineer, but it is not wholly inclusive. The position is a flexible role working directly with Management to lead cross functional Product Development teams in a growing dynamic medical device company. This position ensures exposure to a wide variety of medical devices and manufacturing process technologies. The role should be carried out with consideration of the following.

Job Summary:

  • Based in Galway/Sligo
  • Reporting to the Managing Director or Project Manager
  • Responsible for supporting the wider business as needed.

Duties & Responsibilities include but are not limited to:

  • Support Product Development projects in early phases as a key team member by providing DFM skills, and then leading the development of Manufacturing Processes as the Project transitions through Prototype Phase, into DV and then into Pilot Production.
      • Desired Mfg Process experience includes: Injection Moulding, UV and Solvent Bonding, Catheter Tipping, Laser Welding, US Welding, Pouch and Lid Sealing production fixturing development (3D printing), and test method development
  • Lead the following activities within a Product Development Team:
      • Equipment Specification, IQ/OQ testing, fixturing design and prototyping, Support Design Verification & Validation execution, lead PQ/PPQ initiatives, and provide direction/support to Manufacturing Engineers during the Transfer to Production Phase
      • Strong CAD skills; SolidWorks 3D CAD proficient in complex assemblies, surface modelling – 2d drawings
      • Process validation, including development of test protocols & conducting of testing as per ISO13485
      • Lead Pilot Production trials to assess and optimise Process Capability, including Lead Operator training.
      • Work with Design and Manufacturing teams to complete transfer to Production.

Project Management / Documentation / Quality / PR:

  • Monitor project performance against scope, timing, budget, risk and report variance.
  • Prepare reports to communicate status and results internally and to customers.
  • Compile product specification packages for Production Release (component drawings, inspection criteria, material specs, work instructions, packaging specs etc.)
  • Ensure that documentation such as product development, manufacturing process and test specifications /procedures are completed in compliance with internal and external regulatory and quality requirements.
  • Participate in PR and Sales support activity as required.

Education & Experience:

  • Bachelor’s Degree in Engineering, Science, or similar technical field is preferred.
  • A 5 to 10 year track record of successfully working within cross-functional Product Development teams that bring Class II or Class III medical devices to the market.
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