Engineer , Sustaining

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.

• 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 21 CFR 820 Quality System Regulations, ISO 13485, and ISO 14971 as applicable.
• Identify user needs and develop into design input requirements.
• Formulate verification and validation test plans and collaborate with other Cook departments to execute testing.
• Update device and production specifications accordingly.
• May mentor/coach technicians or other engineering employees (co-ops/interns).

• Bachelor's degree in Engineering or Engineering Technology, or equivalent background.
• Previous project management experience preferred.
• Knowledge of statistical practices as it relates to sample sizes, confidence intervals, capability, risk assessment, and problem solving.
• Knowledgeable with Windows-based software (Word, Excel, Project, PowerPoint, Visio).

We are an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class. Cook will consider qualified applicants with criminal histories in a manner consistent with applicable federal, state/province, and local law.