Cook Medical Sustaining Engineer in Bloomington, Indiana
The Sustaining Engineer at Cook Inc. will lead product and process remediation efforts, in addition to performing sustaining activities for commercially available products. This position will support EU MDR.
Interface with Development Engineering, Production Engineering, Product Management, Regulatory, Clinical, Quality Engineering, Quality Assurance, Operations, sourced vendors, and physicians as necessary to progress projects/tasks.- Manage multiple project timelines, resources and responsibilities to achieve team, departmental, and company goals.- 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.- May supervise / coach technicians or other engineering employees.- 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.
- Bachelors Degree in Biomedical or Mechanical Engineering- Previous project management experience preferred.- Knowledge of statistical practices as it relates to sample sizes, confidence intervals, capability, assessing risk and problem solving.- Proficient in Microsoft Word/Excel/Outlook.
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.
Job Location(s)Bloomington IN United States
Position TypeFull Time