Gurnee, Illinois - PEAK Technical Staffing USA
PEAK is looking for a Sustaining Engineer to help with all Sustaining Engineering as well as being a go-between with manufacturing and technical support. You will become the technical SME for several product lines for a medical device company.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Work closely with and provide engineering support to various cross functional areas such as production, supply chain and quality assurance.
- Resolve manufacturing and testing related issues to ensure repeatability, high yield and manufacturability.
- Create BOMs and Routings for Production.
- Create production and testing work instructions.
- Train production personnel on proper assembly and test procedures.
- Provide engineering support for cost reduction initiatives.
- Provide engineering support in creating equipment preventative maintenance procedures and train production personnel on preventative maintenance,
- Model and release custom configurations and modification to existing and new parts in Solid Works.
- Create validation protocols and validate design modifications in accordance to applicable industry standards and product specification.
- Identify issues, determine root cause and recommend preventive actions to prevent recurrence (CAPA).
- Acquire product and design knowledge required to sustain and improve design and test processes.
- Support the resolution of product design issues and related modifications.
- Participate in Risk Analysis for new and existing product designs.
- Provide recommendations for product enhancements.
- Develop and maintain relationships with key functional groups (i.e. quality, operations, testing, regulatory, sales, etc.).
- Participate in the qualification of new vendors/components.
- Project lead for validations of design modifications and custom configurations.
?Initial travel requirements during the first 3-4 months expected to be approximately 15%.
Education and/ or Experience
BS in engineering.
4+ years’ experience in a manufacturing and sustaining engineering environment.
Strong Manufacturing/Process Engineering experience, specifically involving fluidics, air, valves, regulators, etc.
Familiar with Engineering Changes (requests/Orders) and implementing changes in production.
Ability to pick up new technologies and concepts.
Familiarity with CAD, Solid Works preferred.
Excellent analytical skills and strong attention to detail.
Medical device experience is a plus.
Familiar with Risk Analysis tools such as FMEA, FTA etc. and familiar with ISO 14971_2012