My Client:
A medical device company in Bishopstown, Cork, has developed a breakthrough single-use medical device called Solo+ TTD. This device addresses the pain points of surgical tympanostomy procedures, which are commonly performed on children.
The company, known for its innovative approach, has received several awards, including Seedcorn's Overall Winner and Emerging Medtech Company of the Year.
Job Role:
* Collaborate with cross-functional teams to develop 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 design transfer from R&D to manufacturing
* Collaborate with suppliers to ensure high-quality components and materials
* Implement and manage process controls, including statistical process control (SPC) techniques, test method validation, and process validation activities
Responsibilities:
1. Develop and implement new manufacturing processes
2. Optimize existing processes for productivity, quality, and cost-effectiveness
3. Design, develop, and validate manufacturing processes
4. Conduct risk assessments and implement corrective actions
5. Lead process validation activities
6. Develop and document manufacturing procedures
7. Provide technical support and troubleshooting
8. Collaborate with suppliers and participate in design transfer
Requirements:
* 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
* 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 analytical ability
* Strong communication and interpersonal skills
* Detail-oriented with a commitment to quality and compliance
* Lean Six Sigma methodologies and CAD software experience desirable
$80,000 - $100,000 per year