Senior Product Stewardship Engineer

Job Description

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 109,000 colleagues serve people in more than 160 countries.

Leading an active lifestyle is important to the many people we serve. In Abbott’s Heart Failure division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies in electrophysiology and heart failure (EPHF), allowing people to restore their health and get on with their lives.

For years, Abbott’s MEDICAL DEVICES businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine finger sticks.

The Senior Product Stewardship Engineer will support the Electrophysiology and Heart Failure Divisions. 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 Plymouth, Minnesota location.

WHAT YOU’LL DO

• 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) and its replacement
• 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.

EDUCATION AND EXPERIENCE YOU’LL BRING

• B.S degree with a minimum of eight years combined related experience in a) R&D/S&T b) process engineering c) product stewardship, d) manufacturing, e) inventory control/management f) global sourcing; minimum of two years of experience in Product Stewardship
• Technical experience in chemical, mechanical or biomedical engineering
• Experience in restricted substance management (e.g., REACH, RoHS)
• Medical device manufacturing experience 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.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

· (MFTG ONLY): A fast-paced work environment where your safety is our priority

· (MFTG ONLY): Production areas that are clean, well-lit and temperature-controlled

· 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

Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com

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.

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