My Client is a medical device company based in Bishopstown, Cork. They have developed a breakthrough single-use medical device called Solo+ TTD, which addresses pain points in the treatment of surgical tympanostomy. This procedure involves draining excess fluid from the ear and is commonly performed on children.
About Us
Our company has received several prestigious awards, including Seedcorn's Overall Winner for the Best Early Stage Company in 2014 and Emerging Medtech Company of the Year, Irish Medical Device Association (IMDA) in 2015. We have successfully completed clinical studies, achieved ISO 13485 certification, and obtained CE Mark for the Solo+ device in Europe.
Job Role
* We are seeking a highly skilled manufacturing engineer to collaborate with cross-functional teams and external manufacturers to develop and implement new manufacturing processes.
* This role involves optimizing existing manufacturing processes to improve productivity, quality, and cost-effectiveness.
* You will design, develop, and implement manufacturing processes, including equipment selection, layout, and validation activities.
* Conduct risk assessments and implement corrective and preventive actions as needed.
* Lead process validation activities, including IQ, OQ, and PQ protocols.
* Develop and document manufacturing procedures, work instructions, and quality standards to ensure compliance with regulatory requirements.
* Provide technical support and troubleshooting expertise to resolve manufacturing issues.
* Participate in the design transfer process from R&D to manufacturing.
* Collaborate with suppliers to ensure high-quality components and materials.
* Implement and manage process controls, including statistical process control techniques.
Qualifications and Skills
* Bachelor's or Master's degree in Engineering or a related field.
* Solid experience in medical device manufacturing, operations, and engineering.
* Strong knowledge of manufacturing processes, including assembly, testing, and packaging.
* Experience with quality management systems and regulatory requirements for medical devices.
* Proficiency in process validation, risk management, and statistical analysis techniques.
* Excellent problem-solving skills and ability to analyze complex manufacturing issues.
* Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.
* Detail-oriented with a commitment to maintaining high standards of quality and compliance.
Your Next Career Move
If you are a motivated and experienced manufacturing engineer looking for a challenging role, we encourage you to apply.