Manufacturing Engineer – Balloon Manufacturing (Medical Devices)
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.
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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