PURPOSE AND SCOPE:
The Sr. Disposables Engineer - Operations has wide-ranging of manufacturing experience molding, extrusion, and plastics joining 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 determines methods and procedures on new assignments
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Collaborate with key stakeholders to develop cost reduction strategies and implementation plans that meet business needs
- 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
- Make / Buy analysis, Should Cost Models. Collaborate with engineering teams to optimize component specs that are manufacturable at the required quality and cost goals
- 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
- 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
- Assists with various projects as assigned by a direct supervisor
- Other duties as assigned
PHYSICAL DEMANDS AND WORKING CONDITIONS:
- 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.
- Occasionally lift and/or move up to 50 pounds with assistance.
Bachelor’s Degree required; Advanced Degree preferred.
EXPERIENCE AND REQUIRED SKILLS:
- Minimum 7 - 9 years of related experience; or a Masters’ 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 independently and on time on budget. Project Management Professional (PMP) is a preferred.
- Development of manufacturing and quality KPIs for 6 Sigma process improvement and process capability measurement used in the daily shop floor management (DSFM)
- Proven track record in building relationships and credibility across the organization; work effectively with cross functional teams; able to function in a matrix environment
- Experiment design, statistical skills, and Mini-Tab
- Multiproject experience in solid modeling and developing drawings with Solidworks including tolerance analysis and ability to understand and apply ANSI standards to drawings
- Budgetary responsibility for expenditure and head count
- 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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