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 Qualifications:
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)
