We at GxP Recruitment are delighted to collaborate with our long term Medical Device client on this project. If you are a Process Development Engineer with some equipment experience, this could be the role for you.
Overview of the role
To work closely with R&D Engineering and Manufacturing to develop robust, capable manufacturing processes for the production of medical devices. Multiple projects supporting large automation equipment being used to assemble and test medical devices. Seeing process and equipment builds from concept through to implementation.
Key Responsibilities
* Development of robust (high capability) high yielding processes.
* Optimization of process equipment and technology performance to enable transfer of efficient and repeatable processes to manufacturing.
* Work closely with R&D engineering to develop new medical device designs and transfer validated designs to manufacturing.
* Vendor engagement for equipment design and builds. Supporting these from concept to implementation onsite.
* Equipment design and improvements to existing to update processes to facilitate NPI’s.
* Documentation, preliminary and manufacturing.
* Writing and carrying out validations / qualifications.
* Continued quality improvement.
* Liaise with other relevant functions with regard to ongoing development of current processes and future development needs.
* Develop and maintain expertise in Cork site.
* Will be responsible for commissioning any new microcatheter manufacturing technology, ramping up production, undertaking validations, continuous process improvement and identifying potential development opportunities for medical device technology.
* Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
Qualifications & Experience
* Level 8 degree in relevant Engineering or Science discipline (Manufacturing, Mechanical, Electronic, Production etc).
* 3+ years relevant experience in medical devices
* Excellent interpersonal and communication skills with good leadership abilities.
* Excellent analytical and problem solving skills.
* Experience in at least 1 of the below is required.
Process development and process characterization
Process problem solving
Process validation
DMAIC
Equipment validation
New product introductions
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