Job Description:
My client, a pioneering medical device company based in Cork, has developed the Solo+ TTD, a groundbreaking single-use medical device addressing pain points in surgical tympanostomy procedures. This procedure is commonly performed on children.
About the Company:
The company was recognized as the Seedcorn's Overall Winner for the Best Early Stage Company in 2014 and Emerging Medtech Company of the Year by the Irish Medical Device Association (IMDA) in 2015. The AventaMed team has successfully completed clinical studies, obtained ISO 13485 certification, and secured 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.
* Optimizing 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.
* Implementing and managing process controls, including statistical process control (SPC) techniques, 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.
* 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 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.
* Experience with Lean Six Sigma methodologies is a plus.
* Knowledge of CAD software and experience in design for manufacturability (DFM) is desirable.