Sustaining Engineer 1

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.