Sr. Product Stewardship Engineer

at  Abbott Laboratories

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 114,000 colleagues serve people in more than 160 countries.

EDUCATION AND EXPERIENCE YOU’LL BRING

• A Bachelor’s or Master’s degree in engineering, safety management quality, environmental science, scientific discipline or regulatory affairs
• Technical experience in chemical, mechanical or biomedical engineering
• Experience in product stewardship and/or restricted substance management (e.g., REACH, RoHS) preferred or supplier quality
• Minimum of 5 years’ experience in Product Stewardship or a related field such as Supplier Quality, R&D, operations, technical support, quality or regulatory
• Requires excellent verbal and written communication skills
• Ability to work both independently and across highly diverse teams is required
• Drives functional performance that meets required standards and regulatory compliance

The Senior Product Stewardship Engineer will support the Vascular 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 Westford, Massachusetts location.

• Ensure compliance with geography specific restricted substance requirements (e.g., RoHS, REACH, EU MDR) and Abbott Restricted Substance Management (RSM) requirements
• Change management of implementing EU MDR ((EU) 2017/745) regulation at divisional and corporate level for material compliance element
• Ensure part, packaging, and product information is accurately tracked in database
• Work with Corporate Regulatory/Product Stewardship team and provide updates as needed
• 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
• Work with component suppliers on procuring information for Restricted Substance Management (RSM) requirements
• 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
• 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) and its replacement
• 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