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Sr. Manager, Industrialization Department CaTS

Company: Fresenius Medical Care
Location: Mcallen
Posted on: June 9, 2021

Job Description:

Sr. Manager, Industrialization Department CaTS, Erika of Texas, Inc., a Fresenius Medical Care NA company, McAllen, Texas

Purpose and Scope:

Manages CAPEX and technology transfer engineering team(s). Manages complete implementation of projects including: development of business case, CAPEX process, project planning and execution with equipment validation, and post implementation limited technical support. Recommends enhancements to current business processes to effectively integrate project requirements with existing and related business processes. Assists with defining and managing the creation of policies and procedures that comply with financial practices, FDA, and GMP standards. Provide technical and engineering resources to other CaTS Product Line functions for projects.

Principal Duties and Responsibilities:

  • Work closely with vendors, CAPEX Commodity team, finance, operations and Product Line Strategy to determine "best business case" for investment and to meet the cassettes and tubing system business goals.

  • Manages task schedules related to design transfer for new products and technology transfer of the existing global platform products. Issue progress reports routinely and timely.

  • Validates and documents configuration, enhancements, and development of production processes for industrialization.

  • Creates, optimizes, and drives structured technology transfer schedules and project plans. Sets and meets deadlines with quality deliverables, effectively adapting and modifying plans based on changing conditions or data.

  • Collaborates across all the functional areas (R&D, QA/QC, Operations, etc. Sustaining Engineering, Project Management and Manufacturing Technology Center) necessary to ensure successful project completion and delivery.

  • Anticipates, identifies, documents, and manages project risks; proposes and drives mitigation and contingency including engineering resource deployment and skill development to ensure ample support to other functions within Cassette and Tubing Systems Product Line, e.g. SE, PMO, and Mfg. Tech. Center.

  • Builds effective relationships with core and extended team members, functional managers, senior management, and customers.

  • Ensures reliable manufacturing quality in new automated production processes to support initial product release and/or existing product design modification.

  • Ensures that Engineering projects execution and completion with required Good Manufacturing Practice (GMP) documents and in compliance with the Plant SOP.

This position will oversee and direct cross-functional teams. These positions will include: Industrialization Manager I (1), Industrialization Engineer II (5), Industrialization Engineer I (6), Industrialization Supervisor (2), Sr. Industrialization Engineer (1), Industrialization Technician II (1)

Education Experience and Required Skills:

Position requires a Bachelor's degree (or equivalent foreign degree) in Industrial Engineering, Electrical or Electronic Engineering, Engineering Management, Mechanical Engineering, Manufacturing Engineering or a closely related field and 5 years of experience in the medical product manufacturing industry. Alternatively, will accept a Master's degree (or equivalent foreign degree) in Industrial Engineering, Electrical or Electronic Engineering, Engineering Management, Mechanical Engineering, Manufacturing Engineering or a closely related field and 2 years of experience in the medical product manufacturing industry. Position also requires 2 years of experience (which can have been gained concurrently with the primary experience requirement above) in:

  • Medical device manufacturing processes including extrusion, molding, automation, assembly, and medical product sterilization

  • PLC / PLC programing and AutoCAD or Solidworks equivalent

  • Experiment design, statistical skills, and Mini-Tab

  • Engineering project management including CAPEX, IQ/OQ/PQ, and design control

  • Development of manufacturing and quality KPIs for 6 Sigma process improvement and process capability measurement used in the daily shop floor management (DSFM)

  • Development of specification, acceptance criteria for new manufacturing technologies

  • Budgetary responsibility for expenditure and head count

This position requires 30% domestic and international travel.

Keywords: Fresenius Medical Care, McAllen , Sr. Manager, Industrialization Department CaTS, Other , Mcallen, Texas

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