On a daily basis your work in the Innovation Centre will interact with Quality, Operations and the Design team to develop this system throughout its lifecycle from concepts to market launch. You will own either a process step in a project or a process technology for multiple projects at the Cork Innovation Centre. The project team will develop, qualify & launch a manufacturing process capable of making implants to safety, quality, service and cost standards.
The Ideal Candidate:
A planned and organised individual with strong technical or process knowledge/experience in a regulated industry. A strong team player that will own the delivery of elements within their process/technology area. You will need strong interpersonal skills, be able to collaborate effectively to resolve technical challenges.
1. Process development and value engineering including PFMEA
2. Process Characterisation
3. Process Qualification/Validation
4. Planning of key deliverables into action plans with the help of the Project Manager
5. Regular reporting on the status, performance and risks of your process / technology
6. Participate in DFM reviews with Design Team to minimize lifecycle cost
7. Minimise Environmental and Health & Safety effects of your work
8. Adhere to the company’s procedures as detailed in the SOP manual
9. Support Regulatory Affairs with product submissions
10. All other duties as directed by direct manager
1. Third level degree in Mechanical, Manufacturing, Production Engineering or similar discipline.
1. 1-3 years’ experience in product / process development with Class II / III medical devices or another regulated environment.
2. Self-motivated, with focus on Quality, Delivery and Cost.
3. Proven Root Cause analysis and problem-solving techniques (A3, 8D, TRIZ or equivalent).
1. Certified Project Management qualifications (IPMA or similar)
2. Knowledge of medical device quality & regulatory systems and medical device directive (ISO13485, MDD and FDA CFR 820) and other pertinent Design Control requirements.
3. Certified Six Sigma qualifications.
4. Knowledge of anatomy and physiology.
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