A rapidly expanding medical device manufacturer is seeking a Project Engineer II / Senior Project Engineer to join its high-performing team in Wicklow.
This is a key engineering role focused on supporting new and existing manufacturing projects in a fast-paced, regulated environment.
The successful candidate will have strong project management skills, excellent communication abilities, and a proven track record within medical device manufacturing.
This is an exciting opportunity to contribute to innovative product development and process improvement initiatives, with a focus on plastics and injection moulding.
Responsibilities include but are not limited to: Lead and support technical projects from concept through to validation and implementation on the manufacturing floor.
Collaborate with cross-functional teams including Engineering, Quality, and Operations to execute project plans.
Manage timelines, resources, and documentation to ensure projects are delivered on time and within scope.
Interface with customers and external suppliers to ensure alignment with project requirements and manufacturing standards.
Support process validation activities (IQ/OQ/PQ) in line with regulatory and quality expectations.
Drive continuous improvement and problem-solving initiatives across processes and systems.
Provide technical input on equipment selection, tooling design, and manufacturing methods.
Ensure all project documentation, reports, and protocols meet internal and external standards.
Job Requirements: Degree in Engineering – Mechanical, Manufacturing, Process, or Biomedical preferred.
Minimum of 4–5 years' experience in a regulated medical device manufacturing environment (MNC or contract manufacturing).
Demonstrated experience managing engineering or process development projects.
Strong written and verbal communication skills — able to clearly present ideas, timelines, and technical information.
Experience in injection moulding, tooling, and plastics manufacturing techniques.
Solid knowledge of process validation practices and quality system requirements.
Proficiency with Microsoft Office, including MS Project; knowledge of Minitab or equivalent is an advantage.
Familiarity with CE Marking, GDP, and Lean/6 Sigma methodologies is desirable.
Immediate interviews available for suitable candidates
Note: By applying for this position, you may also be considered by Pale Blue Dot Recruitment for other relevant STEM roles.
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