Project Engineer (NPI)
Posted on Dec 20, 2020 by Dabster Systems
Role: Project Engineer (NPI)
Job Type: Permanent/Contract
Location: Cork, Ireland
- Process development including PFMEA
- Process Characterisation through engineering studies
- Process Qualification/Validation
- Planning & execution of key deliverables & action plans with the help of the Project Manager
- Regular reporting on the status, performance and risks of your project
- Participate in DFM reviews with Design Team to minimize life cycle cost
- Minimise Environmental and Health & Safety effects of your work
- Adhere to the company's procedures as detailed in the SOP manual
- Support Regulatory Affairs with product submissions
- All other duties as directed by direct manager
- Third level degree in Biomedical, Chemical, Manufacturing, Production Engineering, Biochemistry or similar discipline.
- 1-3 years' experience in general engineering.
- Self-motivated, with a focus on Quality, Delivery, and Cost.
- Proven Root Cause analysis and problem-solving techniques (A3, 8D, TRIZ, or equivalent).
- Knowledge of medical device quality & regulatory systems and medical device directive (ISO13485, MDD, and FDA CFR 820) and other pertinent Design Control requirements.
- 1-3 years' experience in cleaning & packaging process development with Class II/III medical devices or another regulated environment.
- Knowledge of Sterility Assurance in a regulated environment.
- Knowledge of anatomy and physiology.