environmental scientist Spencer, IN
Cook Medical Inc
Full Time
Spencer, IN
103042 - 71689 USD ANNUAL Today
Job description
Overview:
The Sustaining Engineer at Cook Inc. will lead product and process remediation efforts, in addition to performing sustaining activities for commercially available products.
Responsibilities:- Interface with Contract Engineers, 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
- Analyze risk using CEA and current FMEAs
- Follow Design Control procedures and comply with requirements of 21CFR820 Quality System Regulations, ISO 13485 and ISO 14971 as applicable
- Identify user needs and develop into design input requirements
- Formulate Verification & Validation Test Plan and collaborating with other COOK departments to execute testing
- Update device and production specifications accordingly
- May supervise / coach technicians or other engineering employees
- Bachelors Degree in Engineering or Engineering Technology, or experience of such kind and amount as to provide a comparable background
- Previous project management experience preferred
- Knowledge of statistical practices as it relates to sample sizes, confidence intervals, capability, assessing risk and problem solving
- Knowledgeable with Windows based software (i.e. Word, Excel, Project, Power Point, Visio)
Cook Medical Inc
www.cookmedical.com
Bloomington, IN
Carl Cook
$1 to $5 billion (USD)
10000+ Employees
Company - Private
Health Care Products Manufacturing
1963
