Job Title:
Process Innovation Specialist
Prominent medical device company in Galway is seeking an experienced professional to develop innovative devices that support heart health.
Key Responsibilities:
* Develop manufacturing processes, materials, and methods for product development using in-house and external paths.
* Design, specify, procure, and qualify process fixtures and equipment.
* Create Work Instructions and supporting documentation for manufacturing processes.
* Execute process characterisation and validation activities.
* Become a technical expert in the assembly and manufacture of products, providing guidance to team members.
* Maintain compliance to quality requirements by building quality into all work aspects.
* Collaborate with internal teams and contract manufacturers to ensure system design meets design input.
* Evaluate relevant process and manufacturing technologies to implement them strategically.
* Manage project plans, tasks, and deliverables to meet deadlines.
Required Qualifications:
* Minimum three years of experience in medical device development, holding a degree in engineering such as polymer, mechanical, manufacturing, or biomedical engineering.
* Fabrication and manufacture of catheter-based medical devices; large calibre delivery systems are advantageous.
* Product and process development, new product introduction skills in medical devices are essential.