My Client:
My client is based in Bishopstown, Cork, and has developed a breakthrough single-use medical device, Solo+ TTD, which addresses pain points of the current treatment for surgical tympanostomy—a procedure that drains excess fluid from the ear. Surgical tympanostomy is the most common procedure performed on children.
This company was crowned Seedcorn’s Overall Winner for the Best Early Stage Company in 2014 and was named Emerging Medtech Company of the Year by the Irish Medical Device Association (IMDA) in 2015. The AventaMed team has successfully completed clinical studies, gained ISO 13485 certification, and obtained CE Mark approval for the Solo+ device in Europe.
Job Role:
* Collaborate with cross-functional teams and external manufacturers to develop and implement new manufacturing processes.
* Optimize existing manufacturing processes to improve productivity, quality, and cost-effectiveness.
* Design, develop, and implement manufacturing processes, including equipment selection, layout, and validation activities.
* Conduct risk assessments and implement corrective and preventive actions.
* Lead process validation activities, including IQ, OQ, and PQ protocols.
* Develop and document manufacturing procedures, work instructions, and quality standards to ensure regulatory compliance.
* 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 the availability of high-quality components and materials.
* Evaluate and select materials, components, and equipment with suppliers to ensure quality and cost-effectiveness.
* Implement and manage process controls, including statistical process control (SPC), test method validation, and process validation activities.
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 the ability to analyze complex manufacturing issues.
* Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.
* Detail-oriented with a commitment to high standards of quality and compliance.
* Experience with Lean Six Sigma methodologies is a plus.
* Knowledge of CAD software and experience in design for manufacturability (DFM) is desirable.
Does this sound like your next career move? To apply or for more information, please forward your application via the provided link or contact me at 0870608656 or colin.clare@lifescience.ie.
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