Engineer 1, Sustaining
On-siteSpencer, Indiana, United States
Job Summary
Lead product and process remediation efforts while performing sustaining activities for commercially available products. Interface with Contract Engineers, Development Engineering, Production Engineering, and other departments to progress projects and tasks. Manage multiple project timelines, resources, and responsibilities to achieve team, departmental, and company goals. Analyze risk using CEA and current FMEAs, and follow Design Control procedures to comply with 21CFR820, ISO 13485, and ISO 14971 regulations. Identify user needs, develop design input requirements, and formulate Verification & Validation Test Plans for execution. Update device and production specifications accordingly. May mentor or coach technicians, co-ops, and interns.
Required Qualifications
- Bachelors Degree in Engineering or Engineering Technology, or experience of such kind and amount as to provide a comparable background
- 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)
Desired Qualifications
- Previous project management experience preferred
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