Contract position: Global leader in the medical product manufacturing industry is looking an Engineer II in Round lake IL. Responsible for reviewing DHF files for FMEAs, Verification and validation reports and some design outputs to build risk files. This is a contract position expected to last 12 months, could be longer based on performance. Currently we are only looking for local candidates. Great Contractor Benefits! Apply Now!Responsibilities for the Product Engineer
Requirements for the Product Engineer
- Responsible for representing the global risk management process in leading Risk file generation
- Facilitate the collaboration of information from medical, R&D, quality engineering and maintain compliance to the quality system in order to generate a risk management file
- Risk Management documentation and Product Requirements management
- Document development work including writing specifications for manufacturing or scientific test results
- Contribute to the planning and execution of components of the development process, which apply to product revision or enhancement or a defined piece of a larger project
- B.S.in Engineering
- Knowledge of device Design History File structure, Risk Management documentation and Product Requirements management
- Ability to develop and execute verification and validation protocols translating product requirements into test / use cases, essential
- Excel (Pivot Tables, V-lookups, etc.)-required, PowerPoint, Outlook, Word, SharePoint
- Previous compliant experience, nice to have
- Nice to have Software: Trackwise 8, Minitab & DOORS
- Paid Vacation
- Health Insurance, and more...
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.