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.
- 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.