Job Information
Cook Medical Sustaining Engineer 2 in Spencer, Indiana
Overview
Engineer 2, 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 2, Sustaining, will typically work independently with general supervision from their team lead/mentor as necessary on moderately complex activities and projects.
Responsibilities
Interface within team/department and with other functional personnel (Production Engineering, Product Management, Regulatory, Clinical, Quality Engineering, Quality Assurance, Operations, sourced vendors, and physicians) as necessary to progress projects/tasks.- Manage multiple project/task timelines, resources and responsibilities to achieve team, departmental, and company goals.- Identify and escalate problems/obstacles and identifies possible solutions to team lead/mentor for discussion and resolution. Utilize critical thinking and past experiences to inform project/task decisions.- Presents project/task status updates to team members and team lead/manager. May also present to other functional leadership as necessary.- Provides guidance and assistance to technicians or newer engineering employees/co-ops/interns/contractors. May review and approve outputs from less experienced engineers/contractors/co-ops/interns.- Demonstrates practical/detailed design and risk knowledge of 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 and minimum 3 years of prior relevant experience. Advanced degrees may reduce the experience requirement by 1-2 years.- Project management experience- Familiarity with statistical practices as it relates to sample sizes, confidence intervals, capability, assessing risk and demonstrated problem solving experience.- Proficient in Microsoft Word/Excel/Project/Outlook, JBase, Engineering Server, Business Objects.
Requisition ID2024-14700
Posting Date3 weeks ago(6/5/2024 12:18 PM)
Job Location(s) Spencer IN United States
Position Type Full Time
Company Cook Inc - Spencer
Category Engineering