Engineer 1, Sustaining
Job Location:
Spencer, WI - USA
Monthly Salary:
Posted on:
Vacancies:
Department:
Job Summary
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.
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 withother 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)
Required Experience:
IC
About Company
Cook Medical is a family-owned medical device company that works with physicians to develop devices that are less invasive for patients.
