Cook Medical Sustaining Engineer in bloomington, Indiana
The Sustaining Engineer at Cook Inc. will lead sustaining activities for commercially available products and/or product and process remediation efforts.
• 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
This particular position is focused on leading sustaining activities for commercially available products.
• 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) of this employment position.
Job Location(s)Bloomington IN United States
Position TypeFull Time