Title: Product Engineer (Medical Device)
Location: Lake Forest, Illinois
Duration: 12 Month Assignment
This is a support role for the IVDR program (In-Vitro Diagnostic Medical Devices Regulation) which is a European regulation that ensures the safety and performance of in vitro diagnostic medical devices; it aims to improve clinical safety, reduce risk of discrepancies in interpretations across EU.
Responsibilities:
- 100 % Desk job conducting Stewardship Activities.
- Person will assess products and packaging for compliance with regulations and will submit any issues or concerns by documenting these and submitting these for review.
- Information is tracked in multiple databases.
- Provides product status updates to other teams.
- Works with various groups on component changes in the manufacture, import and distribution of any new product or relocation of manufacturing processes within the project scope.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Takes the Reagent liquid Kit and inputs it into an Integrated Clinical Chemistry & Immunoassay System called the ALINITY ci-series for analysis and overall assessment of the contents.
- Assessment of contents includes any changes needed, bill or materials, reports and analysis against regulatory requirements.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.
Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.