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Device Regulations Project Engineer

Apply Now Job ID R-352585 Date posted 11/09/2019

Locations

Broken Bow, Nebraska

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.

Job Description

The essential functions of this position include but are not limited to:

  • 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/labelling.
  • 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 changeovers and inventory write-off of labels and packaging inventory.

Education

Bachelor Degree required, engineering or science-based discipline preferred, other relevant experience will be considered (see below).

Experience

Minimum of 3 years in a manufacturing plant engineering role.

Experience in medical device manufacturing is preferred and must have a proven track record in implementing change.

Experience in manufacturing engineering or quality.

Device regulation knowledge is a plus.

Must have knowledge of design control and validation processes.

Engineering background, preferable controls or IT; alternatively, packaging engineer with mechanical background.

SAP knowledge and experience is a plus.

Primary Work Location

USA NE - Broken Bow

Additional Locations

Work Shift

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