Application Analyst II-Environmental Monitoring Software

Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively seeking an Application Analyst II-EMS that works directly with the Quality & Regulatory teams within Arthrex and would be doing business application configuration and support in the implementation of a new environmental monitoring software solution and hardware across global locations. This role will include responsibilities to drive optimization of the environmental monitoring solution after implementation as well as expand support across applications supported by the IT Quality Team.  Excellent communications and analytical skills, strong technical project management skills and a Bachelors’ degree will be essential for this position. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

• Knowledge expert in Environmental Monitoring application system
• Expertise in application configuration
• Support of Applications
• Participates in gathering user/customer requirements
• Participates in relaying information for vendor support
• Ability to train users on EMS, MES, PLM, QMS, DMS, BI, and related systems
• Maintain documentation and change control
• Analyze business process potentials for streamlining and improvements in efficiencies
• Analyze business process requirements and develop functional/system specifications.  
• Articulate design considerations, trade-offs, benefits, and recommendations for technical solutions with scalability and supportability in mind. 
• Ensure appropriate regulations and standards, such as but not limited to 21 CFR Part 11, 21 CFR 820, and ISO 13485, are addressed in software validations. 
• Assist validation and testing activities of cross-functional teams that include technical functions such as IT, Software QA, Business Subject Matter Process Experts. 
• Assess the impact of system changes thru change management and change control systems; participate in the planning and implementation of change. 
• Participate in writing specifications for programming projects
• Project Management
• This is an in-office position located in Naples, Florida; it is not a remote position.

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:

• Bachelors Degree required.  Degree in Computer Science or related field preferred.[SE1] 
• At least two years experience in at least one of the following (two or more preferred):
  1. Environmental Monitoring System (EMS) experience preferred
  2. Quality Management System (QMS) - IQVIA Smartsolve or TrackWise Legacy experience a plus
  3. Document Management System (DMS) – SharePoint and/or Open Text Documentum experience a plus
  4. Manufacturing Execution Systems (MES) – Oracle discrete manufacturing experience a plus
• Experience in a manufacturing environment preferred (Life Sciences experience a plus)
• Experience with analytical/reporting tools (Crystal Reports, SSRS, Power BI, etc.) a plus

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

• Excellent communication skills and customer service orientation
• Microsoft SQL knowledge and experience a plus
• APICS, PMP, SAP, Microsoft certifications a plus
• Understanding of Cloud Architecture concepts, a plus

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.