The Sustaining Engineer at Cook Inc. will lead product and process remediation efforts, in addition to performing sustaining activities for commercially available products.
• 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)
**Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.