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À propos
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Location: Galway, Ireland
Open to International Candidates (Visa Support Available)
About the Role
We are seeking an experienced Manufacturing Engineer with direct Balloon Manufacturing experience to join a leading cardiovascular medical device manufacturer in Galway.
This role is specifically focused on medical balloon forming and commercial manufacturing. Candidates without hands-on balloon manufacturing experience will not be considered.
Key Responsibilities
- Develop, optimize and scale medical balloon forming processes (stretch blow moulding / balloon blowing).
- Define and control critical balloon forming parameters including: Temperature profiles, Pressure curves, Stretch ratios, Cycle times
- Establish robust, repeatable commercial balloon manufacturing processes.
- Lead balloon-related process validations (IQ, OQ, PQ).
- Troubleshoot balloon defects such as:
- Wall thickness variation
- Non-uniform expansion
- Dimensional non-conformance
- Use statistical analysis and Six Sigma tools to drive yield and performance improvement.
- Support new balloon catheter product introductions from development to full-scale manufacturing.
- Ensure compliance with GMP, FDA and ISO 13485 standards. xcfaprz
Essential Experience (Must-Have)
3–7+ years’ experience in medical balloon manufacturing
Direct hands-on experience with balloon forming / balloon blow moulding processes
Experience working with balloon materials such as PET, Nylon, Pebax or similar
Strong understanding of: Compliance curves, Rated burst pressure (RBP), Wall thickness control, Dimensional tolerancing
Experience executing equipment and process validation (IQ/OQ/PQ)
Background in cardiovascular catheter manufacturing preferred
Applications without direct balloon manufacturing experience will not be shortlisted.
Qualifications
- Level 8 Degree (or equivalent) in Engineering (Mechanical, Biomedical, Materials or related discipline)
What’s on Offer
- Competitive salary + benefits
- Relocation and visa support for international candidates
- Opportunity to join a high-performing cardiovascular technology team
- Long-term career progression within a global medical device organization
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Compétences linguistiques
- English
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