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Fresenius Medical Care North America Sr. Manager, Industrialization Department CaTS in McAllen, Texas

Job ID 20000BCA

Available Openings 1

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

Purposeand 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 Dutiesand Responsibilities:

  • Work closely withvendors, CAPEX Commodity team, finance, operations and Product Line Strategy todetermine “best business case” for investment and to meet the cassettes andtubing system business goals.

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

  • Validates anddocuments configuration, enhancements, and development of production processesfor industrialization.

  • Creates, optimizes, and drives structured technology transfer schedulesand 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 ManufacturingTechnology Center) necessary to ensure successful project completion anddelivery.

  • Anticipates, identifies, documents, and manages project risks; proposesand drives mitigation and contingency including engineering resource deploymentand skill development to ensure ample support to other functions withinCassette 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 reliablemanufacturing quality in new automated production processes to support initialproduct release and/or existing product design modification.

  • Ensures thatEngineering projects execution and completion with required Good ManufacturingPractice (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)

EducationExperience 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 processesincluding extrusion, molding, automation, assembly, and medical productsterilization

  • PLC / PLC programing and AutoCAD orSolidworks equivalent

  • Experiment design, statistical skills, andMini-Tab

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

  • Development of manufacturing and qualityKPIs for 6 Sigma process improvement and process capability measurement used inthe daily shop floor management (DSFM)

  • Development of specification, acceptancecriteria for new manufacturing technologies

  • Budgetary responsibility for expenditureand head count

This position requires 30% domestic and international travel.

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