Sustaining Engineer 1
Cook Medical
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.
- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.- Must strictly adhere to safety requirements.- Maintain regular and punctual attendance.- Must maintain company quality and quantity standards.- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments withminimal supervision.- Ability to remain calm and receptive in fast paced situations.
Qualifications
- Bachelor's degree in Engineering or Engineering Technology or related discipline.- Proficient in Microsoft Word/Excel/Outlook.
Physical Requirements:
- Works under general office environment conditions.- Utilizes close visual acuity for working with computers and equipment.- Frequently required to sit, stand, walk, and communicate.
- Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.
**Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.**
Requisition ID2024-15584
Posting Date3 days ago(11/15/2024 12:56 PM)
Job Location(s)Bloomington IN United States
Job LocationsUS-IN-Bloomington
Position TypeFull Time
CompanyCook Inc - Bloomington
CategoryEngineering
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