- 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
- 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
- At Abbott, you can have a good job that can grow into a great career. We offer:
- A fast-paced work environment where your safety is our priority (Manufacturing roles only)
- Production areas that are clean, well-lit and temperature-controlled (Manufacturing roles only)
- Training and career development, with onboarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives and retirement plans
- Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
- Paid time off
- 401(k) retirement savings with a generous company match
- The stability of a company with a record of strong financial performance and history of being actively involved in local communities
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Sr. Product Stewardship Engineer - Westford, United States - Abbott Laboratories
Description
VASCULAR DIVISION
Leading an active lifestyle is important to the many people we serve. In Abbott's Vascular division, we're advancing the treatment of heart and vascular disease through breakthrough medical technologies in Vascular, allowing people to restore their health and get on with their lives.
WHAT YOU'LL DO
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.
EDUCATION AND EXPERIENCE YOU'LL BRING
WHAT WE OFFER
Learn more about our benefits that add real value to your life to help you live fully:
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $72,700.00 – $145, In specific locations, the pay range may vary from the range posted.