The Product Stewardship Engineer will support the Medical Device 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.
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 our clients 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 & COMPETENCIES:
B.S degree with a minimum of three years required, M.S. preferred; 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 if needed.
For a detailed and confidential discussion on the role please contact Christopher O Toole.