Process Development Engineer
Job Description Overview
This job description sets out to define the job role of a Process Development Engineer, but it is not wholly inclusive. The position is a flexible role working within a cross functional Product Development team 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.
Based in Galway/Sligo
Reporting to the Tech Lead 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 and support 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.
Education & Experience:
- Bachelor’s Degree in Engineering, Science, or similar technical field is preferred.
- A 3 to 5 year track record of successfully working within cross-functional Product Development teams that bring Class II or Class III medical devices to the market.