My Client:
My client are based in Bishopstown, Cork and have developed a breakthrough single-use medical device, Solo+ TTD that addresses pain points of the current treatment of the surgical tympanostomy, a procedure that drains out the excess fluid built up in the ear. The surgical tympanostomy is the most common procedure done on children.

This company was crowned 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. The AventaMed team have successfully completed clinical studies,gained ISO 13485 certification, and obtained CE Mark for the Solo+™device in Europe.

Job Role:

• Collaborating with cross-functional teams and external manufacturers to develop and implement new manufacturing processes.
• Optimising existing manufacturing processes to improve productivity, quality, and cost-effectiveness.
• Designing, developing, and implementing manufacturing processes, including equipment selection, layout, and validation activities.
• Conducting risk assessments and implementing appropriate corrective and preventive actions.
• Leading process validation activities, including IQ, OQ, and PQ protocols.
• Developing and documenting manufacturing procedures, work instructions, and quality standards to ensure compliance with regulatory requirements.
• Providing technical support and troubleshooting expertise to resolve manufacturing issues.
• Participating in the design transfer process from R&D to manufacturing.
• Collaborating with suppliers to ensure the availability of high-quality components and materials.
• Collaborating with suppliers to evaluate and select materials, components, and equipment, ensuring the highest quality and cost-effectiveness.
• Implementing and managing process controls, including statistical process control (SPC) techniques, test method validation and process validation activities.

• Bachelor's or Master's degree in Engineering or related field.
• Solid experience in medical device manufacturing, operations, and engineering.
• Strong knowledge of manufacturing processes, including assembly, testing, and packaging.
• Strong 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 analyse 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.
• Experience with Lean Six Sigma methodologies is a plus.
• Knowledge of CAD software and experience in design for manufacturability (DFM) is desirable.