What are the responsibilities and job description for the Sustaining Engineer position at Cook Group?
Overview
Engineer 1, Sustaining, will perform activities related to sustaining commercially available products. These activities may include (but are not limited to) product/process remediation, risk analysis, regulatory approval support, and product/process improvements. The Engineer 1 will typically work under close supervision from their team lead/mentor on more defined/less complex activities and projects.
Responsibilities
- Interface within team/department to complete activities while building relationships with other functional personnel (Regulatory Affairs, Manufacturing Engineering, Supplier Engineering, Quality Assurance, Operations, R&D).- May manage project/task timelines, resources and responsibilities to achieve team, departmental, and company goals.- Identify and escalate problems/obstacles and work with team lead/mentor to resolve. Utilize basic problem-solving skills to inform project/task decisions.- Presents project/task status updates to team members and team lead/manager- Develop basic product design and risk knowledge around relevant product lines- Follow Risk Management procedures and comply with requirements of ISO 14971 as applicable. - Follow Design Control procedures and comply with requirements of 21CFR820 Quality System Regulations and ISO 13485 as applicable. - Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
Qualifications
- Works under general office environment conditions.- Utilizes close visual acuity for working with computers and equipment.- Frequently required to sit, stand, walk, and communicate.
