Job Description
Seeking an experienced Manufacturing Engineer to join a pioneering medical device company in Cork, Ireland, responsible for developing and implementing manufacturing processes for a breakthrough single-use medical device.
My Client is a leading medical device company based in Cork, Ireland, that has developed a breakthrough single-use medical device, Solo+ TTD, addressing pain points in the current treatment of surgical tympanostomy. This procedure is the most common done on children.
The company has achieved significant milestones, including being 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 team has successfully completed clinical studies, gained ISO 13485 certification, and obtained CE Mark for the Solo+ device in Europe.
Job Role:
- Collaborate with cross-functional teams and external manufacturers to develop and implement new manufacturing processes.
- Optimise 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 appropriate 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 compliance with regulatory requirements.
- 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.
- Implement and manage 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 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.