Job Title:
About the Role:
We are seeking a highly skilled Lead Manufacturing Engineer to join our team in Cork, Ireland.
The ideal candidate will have extensive experience in medical device manufacturing and be responsible for interacting with contract manufacturing facilities to ensure product supply to the market.
Key Responsibilities include collaborating with cross-functional teams, designing and implementing manufacturing processes, conducting risk assessments, and providing technical support.
Responsibilities:
* 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.
* Identifying and implementing automation and technology advancements to improve efficiency, productivity, and quality in manufacturing operations.
* Ensuring compliance with relevant regulatory standards, such as FDA regulations and ISO requirements.
Qualifications and Skills:
* 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.
This is a fantastic opportunity to join a leading organisation and contribute to the development of innovative medical devices.