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, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
The Product Stewardship Engineer will support the Structural Heart Division. This position will lead and support the product stewardship activity and EHS development, implementation and management of the product stewardship and restricted substance programs. This position will sit at our Woodridge, Minnesota location.
- Change management of implementing EU MDR ((EU) 2017/745) regulation at divisional and corporate level for material compliance element
- Six Sigma based improvements for existing processes/new process design for REACH ((EC) 1907/2006), RoHS (EU Directive 2011/65/EU and (EU) 2015/863), California Prop65 and other material compliance regulations
- Support the implementation of Windchill Products Analytics (product stewardship database)
- Ensure part, packaging and product information is accurately tracked in database
- Work with Corporate Regulatory/Product Stewardship team and provide updates as needed
- Ensure compliance with geography specific restricted substance requirements (e.g., RoHS, REACH, EU MDR) and Abbott Restricted Substance Management (RSM) requirements
- Facilitate, track and work with various groups on component changes in the manufacture, import and distribution of any new product or relocation of manufacturing processes
- Facilitate division compliance with all RSM reporting requirements
- Coordinate with R & D support, the implementation and integration of RSM evaluations
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
- Maintains positive and cooperative communications and collaboration with all levels with employees, customers, contractors, and vendors
- Supports Environmental Management System, ISO 14001 and division sustainability efforts
- Performs other related duties and responsibilities, on occasion, as assigned.
- B.S degree with a minimum of four years combined related experience in a) inventory control/management b) process engineering c) global sourcing d) manufacturing
- Technical experience in chemical or mechanical engineering
- Medical device manufacturing experience preferred
- Experience in restricted substance management (e.g., REACH, RoHS) preferred
- Experience working in a broader enterprise/cross-division business unit model preferred.
- Must possess critical thinking, problem solving and planning skills
- Must use sound judgement and ability to build and maintain relationships with individuals and in teams
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Ability to travel approximately 10%, including internationally.