Manufacturing Engineer II

5 hours ago

Galway, Ireland Hero Recruitment Full time

Manufacturing Engineer II - Balloon Forming

We are seeking a motivated and technically strong Manufacturing Engineer to join a core engineering function within a regulated healthcare manufacturing environment. The successful candidate will apply engineering expertise, validation experience and continuous‑improvement methodologies to develop, optimise and validate robust, repeatable manufacturing processes that deliver high quality product and efficient throughput.

Main Responsibilities

- Lead assigned engineering tasks and project work to successful, on‑time outcomes.

- Design, implement and maintain process controls to ensure robust, repeatable commercial manufacturing.

- Drive continuous improvement initiatives to maximise process performance, yield and OEE.

- Apply scientific problem‑solving (analytical and experimental) to identify root causes and implement corrective actions.

- Ensure engineering activities, designs and changes comply with GMP, QA/regulatory and EHS standards.

- Collaborate with Automation/Controls Engineering to develop and stabilise new processes and equipment.

- Provide technical support for new product/technology introductions and manage engineering change control activities.

- Assess and manage non‑conforming products/processes in accordance with established procedures.

- Plan and execute validations and qualifications (IQ/OQ/PQ), utilising statistical tools and Six Sigma techniques.

- Mentor and help develop in‑house subject matter expertise across core manufacturing technologies.

- Participate in process/equipment risk assessments (e.g. FMEA) and other risk analyses to protect product and user safety.

- Prepare and present regular progress updates and metrics to senior management; chair or contribute to routine manufacturing/engineering meetings.

Qualifications & Experience

- Honours degree (Level 8) in Engineering or a closely related discipline, or equivalent.

- Minimum 3–5 years’ professional experience in a Manufacturing Engineering role within the medical device / healthcare sector (or closely regulated manufacturing environment).

Desired Skills & Experience

- Balloon forming experience is required — demonstrable ability to determine and optimise forming parameters for yield and functional performance.

- Proven track record of delivering continuous improvement projects with measurable benefits.

- Experience planning and executing validations and equipment qualifications (IQ, OQ, PQ).

- Strong statistical and Six Sigma/lean capability — able to apply tools to validation and process improvement.

- Proficiency in CAD tools for process design and equipment support.

- Excellent technical documentation and report‑writing skills with high attention to detail.

- Thorough knowledge of regulatory requirements and quality standards applicable to medical device manufacturing (GMP, ISO, etc.).

- Strong interpersonal skills and the ability to work effectively across cross‑functional teams.

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