Medical Device Industry- Project Engineer-1 year contract
This person will split their time between 2 key projects;
one project is a compliance project to assess gaps to an updated ISO standard, and the recommend and execute DHF (design history file) updates.
The second project is a major cost reduction project for the entire key product line where we are looking to replace the current urethane adhesive with a lower cost alternative. This project has high impact, and an error here could put our whole portfolio at risk
Top three skill sets:
- Project management skills to guide work assignments, self regulate workload and time and own goals with minimal oversight.
- 50% workload: Legacy product file remediation skills, to understand compliance gaps in technical documentation to current standards, especially ISO 80369-7 Luer Ports. Skill set includes recommending and executing a balanced remediation strategy between minimizing risk and speed to execution, understanding that with a large legacy portfolio we are after improvement, not perfection.
- 50% workload: Cost out project experience with implementing product improvements, understanding risk assessment and testing required to assure no negative impact to product
Nice to have: urethane based adhesives experience
Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
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Engineering Design Process