BD (Becton, Dickinson and Company) Device Regulation Project Engineer in New Jersey
Job Description Summary
Reporting to the Engineering Manager or delegate, the Device Regulation Project Engineer’s role is to drive plant implementation for the EU Region MDR/IVDR regulatory requirements. Must be able to effectively plan/track, collaborate, and manage the actions of different functions to deliver compliance to these regulations by the required deadlines. In addition, this role will personally handle all facets of the regulatory changes as the plant/site project leader, including communicating material and process information to Specimen Management Business Group project team, executing equipment specification, procurement, implementation and validations, and coordinating packaging/material procurement and inventory run-out with Procurement as appropriate.
Lead all EU MDR/IVDR activities for site.
Technical assessment of UDI and Date of Manufacture to all levels of packaging
Identifying gaps against EU MDR/IVDR requirements and current packaging/labeling.
Prepare accurate timelines for all program and project tasks.
Liaise with the quality, regulatory, facilities, production and marketing departments to obtain their input and / or support to ensure program is successfully initiated and validated within time frame and budget.
Supports and advises plant leadership on MDR/IVDR program.
Acts as link between Franklin Lakes Specimen Management Business Group Project Team and plant resources (Plymouth, Broken Bow, Sumter, Juncos); provide communication directly with IDC. One person point of contact for all EU MDR/IVDR information collection and distribution, including but not limited to – validations, process maps, process aids and other information as needed.
Actively seeks opportunities to, and liaise with other PAS sites to share learnings and copy best practices
Ability to handle several assignments (project and process duties) simultaneously and coordinate and execute multiple facets of projects; including, but not limited to equipment procurement, implementation and validation.
Accountable for spending (capital and expense) within approved limits of program.
Coordinate “system” activities such as changes to SAP and BOM’s.
Documentation review for content, accuracy and completeness, including: Labels, IFU’s, Manufacturing section of STED
Coordinate activities with planning and production groups to ensure minimize change-overs and inventory write-off of labels and packaging inventory.
COMPETENCIES and Technical Skills Essential to this Position:
Continuous and Versatile Learning
Driving for Results
Managing, Leading and Developing People
Promoting an Inclusive Work Environment
Minimum of 5 years in a manufacturing plant engineering role
BS Degree in Engineering or related discipline.
Engineering background, preferable controls or IT; alternatively, packaging engineer with mechanical background
SAP knowledge and experience is a plus
Experience in medical device manufacturing is preferred and must have a proven track record in implementing change. Will also have experience in manufacturing engineering or quality.
Device regulation knowledge is a plus
Must have knowledge of design control and validation processes.
Lean and Six Sigma methodology knowledge is a plus
- Individuals have the authority to execute all responsibilities detailed within their job description and any procedures or processes in C2C or otherwise.
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.
Primary Work LocationUSA SC - Sumter
Work ShiftUS BD 1st Shift 8am-5pm (United States of America)
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.