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Business Analyst III - LIMS, Sterilization, Engineering & Regulatory in Naples, FL ,  at Arthrex

Date Posted: 11/7/2018

Job Snapshot

Job Description

Requisition ID:
Business Analyst III - LIMS, Sterilization, Engineering & Regulatory
Arthrex, Inc.
Ave Maria, FL

Main Objective:

The Business Analyst III Laboratory, Sterilization, Engineering & Regulatory position works directly with business departments within Arthrex to build and manage a pipeline of Information Technology projects and enhancements. A successful candidate must have experience defining and operating business processes in the following areas: Engineering, Regulatory, Manufacturing and Quality. The position liaises with the technical organization to determine the timing and cost of specific projects, also engages in process improvement efforts to optimize the effectiveness of technology investments. This position also works with business in gathering requirements, project management and communication liaison with Business Users.

Essential Duties and Responsibilities:

  1. Participates in gathering user/customer requirements including master data governance
  2. Deploy an appropriate methodology for the identification and documentation of business requirements.
  3. Assist in with process, tools and documentation for Engineering, Regulatory, Laboratory
  4. Ability to train users on ERP, PLM, PDM, LIMS and related systems
  5. Maintain documentation and change control to comply with CFR Title 21 820
  6. Analyze business process potentials for streamlining and improvements in efficiencies
  7. Meet regularly with departments to solicit feedback on needs
  8. Project Management and mentorship of junior-level analysts
  9. Lead demand planning and scheduling of Engineering, Regulatory, Sterilization and Laboratory functional areas
  10. Translate business goals and objectives into strategic business capabilities. 
  11. Continuously analyze and document as-is process and process interfaces
  12. Systematic updating and creation of system documentation, business process documentation, and end user documentation.
  13. Benchmark current and future processes against best industry practices.
  14. Develop a roadmap of projects and initiatives for enablement of new capabilities.
  15. Accountable for adoption of solutions by sponsoring business departments.
  16. Up to 20% travel required

    Incidental Duties:

The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

Education and Experience:

  • Bachelor's degree required, preferably in Business, Engineering or Computer Science or related field required. Masters degree in Business or Engineering preferred
  • At least five years’ experience within a business function (Laboratory) with business analysis or business process improvement activity required
  • At least five years’ experience with LIMS, PLM, PDM, ERP (SAP)
  • Experience with the following modules: Laboratory Sample Management, Scheduling Tools, Result Entry, Lab Instrument Integrations, Validation and Qualification processes under 21 CFR 820 industry settings.
  • Experience or team participation with implementing LIMS, ERP, PLM & PDM Technologies
  • Proficient in Testing and Documentation using proper methodologies
  • Previous involvement in the deployment or optimization of an ERP system a plus
  • Previous position in Pharma or Medical Device industry a plus
  • Experience working in projects where multiple functions work in a matrix structure a plus

Knowledge and Skill Requirements/Specialized Courses and/or Training:

  • Support clinical lab to identify, define and document business needs and objectives, current operational procedures, problems, input and output requirements, and levels of systems access.
  • Knowledge of Lab instruments, interfaces and working with laboratory equipment.
  • RDBMS Knowledge preferable MSSQL, Oracle
  • Siemens Unilab Knowledge (both Functional and Technical)
  • Ability to drive Manufacturing, Quality technology implementations through planning, process design, user acceptance testing, etc.
  • Experience with process improvement techniques and tools. Lean or Six Sigma preferred.
  • Customer service orientation
  • Understanding of the major functions in a global organization.
  • Strong communication (written and oral) and presentation skills.
  • Ability to work comfortably at all levels within the organization up to the senior management level.

Machine, Tools, and/or Equipment Skills:

PC servers, workstations and laptops. Telecommunication equipment, cell phones and smart phones. Microsoft and Apple environment. Work with standard current computer applications, such as word processing, spreadsheets and data bases. MS Office, SQL server, Active Directory, MS Exchange, ERP and partner software applications.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.