Engineer 1, Sustaining

Sustaining Engineer

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)

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)