Fresenius Medical Care Job - 37081792 | CareerArc
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Company: Fresenius Medical Care
Location: Lawrence, MA
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech


Job ID 210000W4

Available Openings 1


The Disposables Engineer - Operations has wide-ranging of manufacturing experience molding, extrusion, and plastics joining in medical industry to develops and designs cost savings initiatives with continuous reliability improvements. Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Networks with key contacts outside own area of expertise and determine methods and procedures on new assignments


  • Responsible for being the project team leader and overseeing the all aspects of a project from cradle to grave, complete ownership, Project activities include project plans, budgeting, timelines, project reporting, risk and mitigations strategies
  • Breakdown complex business needs and translate them into actionable system level projects to address those needs
  • Make / Buy analysis Should Cost Models. Collaborate with engineering teams to optimize component specs that are manufacturable at the required quality and cost goals
  • Generate investment proposal that can that could add value to the core business in Operations.
  • Collaborates across all the functional areas (R&D, QA/QC, Finance, etc. Sustaining Engineering, Project Management and Manufacturing Technology Center) building effective relationships with both subordinates and senior management to ensure successful project completion and delivery
  • Ensure reliable manufacturing quality in new automated production processes to support initial product release and/or existing product design modification
  • Lead and/or conduct technical scouting for innovation in manufacturing technology as product quality evaluation technologies
  • Ensure that Engineering projects execution and completion with required Good Manufacturing Practice (GMP) documents and in compliance with the Plant SOP
  • Lead improvement and corrective action projects using techniques such as DMAIC or 8-D and appropriate statistical tools
  • Plan and execute process validations. IQ/OQ/PQ/PPQ - CPVP preferred
  • Will lead the design control process, including writing design inputs, subsystem requirements, component specifications, design plans and risk analysis
  • Plan and lead product verification and product validation according with internal procedures and FDA design control Guidance
  • Expected to contribute technically or procedurally to the development of the operations team
  • Assists with various projects as assigned by a direct supervisor
  • Other duties as assigned


  • The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


  • Bachelor's Degree required; Advanced Degree preferred.
  • Master's degree preferred


  • Minimum 3-5 years of related experience; or a Master's degree with 6 years' experience
  • Extensive Medical device manufacturing processes knowledge including extrusion, molding, automation, assembly, sterilization and validation
  • Experience in the following: Engineering materials - plastics, metals and metal alloys, ceramics, composites. Plastic manufacturing processes; high pressure injection molding, low pressure injection molding, vacuum forming, general assembly and fabrication. Plastic bonding methods and bonding materials and adhesives
  • The position requires excellent organizational and communication skills and a proven track record managing significant portions of projects self-directed and on time on budget meeting stakeholder expectations. Project Management Professional (PMP) is a preferred
  • Experiment design, statistical skills, and Mini-Tab
  • Proven ability to organize, analyze, and interpret data to generate insights and conclusions
  • Proven ability to deal with some degree of ambiguity/uncertainty and a willingness to try new/challenging things
  • Proficiency with Microsoft Office Products and project management software
  • Advance skills for Microsoft excel
  • Multi-project experience in solid modeling and developing drawings with Solid works including tolerance analysis and ability to understand and apply ANSI standards to drawings
  • Excellent presentation, and communication skills through English in both written and verbal form
  • 25% travel, some international

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.

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