What are the responsibilities and job description for the Engineer 1, Sustaining position at Cook Medical?
Overview
The Sustaining Engineer at Cook Inc. Spencer will lead product and process remediation efforts, in addition to performing sustaining activities for commercially available products.
Responsibilities
The Sustaining Engineer at Cook Inc. Spencer 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 mentor/coach technicians or other engineering employees (co-ops/interns)
- 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)