Job Description :
Job Summary:
The Senior Systems Analyst will be directly involved in conducting analysis, creating technical/functional specs, configuration, testing, implementation, system administration and support of new and existing server based applications supporting medical device product development.
This role will provide expertise that is critical in assisting with the identification of opportunities for the effective use of technology and the implementation of IT solutions on behalf of internal business product development groups.
Job Duties:
Maintains technology standards for development and maintenance of new and existing systems, makes recommendations for improvement. Specifically, for LIMS/LIS, ELN, LES, SDMS and/or CDS systems
Ensures quality documentation and development, performing activities for application implementation and enhancements, specifically for LIMS/LIS, ELN, LES, SDMS and/or CDS systems
Server based application implementation and support, specifically LIMS/LIS, ELN, LES, SDMS and/or CDS systems
Collaborates with internal customers to ensure user requirements are complete and concise, confirming that changes and enhancements meet technical specifications and user requirements
May interact with the business to elicit, analyze and document detailed requirements
Performs process analysis to define technical configuration requirements
Transforms business requirements into technical documentation including detailed design/configuration specifications to describe program development, logic coding and corrections
Performs a variety of tasks to review, analyze and modify business application systems including configuration, testing, debugging, implementation, system administration and support
Performs system integrations or API configuration between systems
Makes appropriate recommendations for continuing, modifying, or abandoning proposed projects based on the results of feasibility studies and/or cost/benefit analyses
Maps current processes to the desired state and identifies gaps such as program functions, output requirements, input requirements and sources, data conversion strategies, and system techniques and controls
Provides solid test designs, develops test cases and reviews/approves the execution of those test cases and executes test cases
Develops business process flows and data models for new system development or for process redesign
Contributes to end-user training as needed
Provides support to existing applications and resolves business and technical problems
Keeps informed of trends and new developments in technology to better advise management of means to accomplish business and information systems goals
Communicates effectively with management to enhance their understanding of the opportunities and limitations of information systems
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
Integrates and designs data privacy and security by design
Works with infrastructure engineers and other application teams to implement solutions that provide excellent access, throughput, availability, security and cost-effectiveness, while maintaining simplicity and industry best practices
Accountable for product lifecycle planning, software and hardware update planning for client server applications
Maintains accurate current state application architecture diagrams, documentation, and other data sources in a consistent and replicable manner
Develops detailed implementation, test and roll-back procedures for planned changes
Applies enterprise data privacy and security policies/standards when performing all new project and operational duties
Identifies tasks and processes requiring automation and implements the most effective solution
Act as a 3rd level support and root cause analysis
Follows standard change management procedures
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
Performs other related duties and responsibilities, on occasion, as assigned.
Equipment:
Works with standard office equipment, telephone, cellular phone, and personal computer. Operates a motor vehicle for trips to various Company sites and outside vendor, field, and customer locations; and to commute to various airports for airline travel.
Working Conditions:
Work environment varies from well lighted office/cubicle, low to moderate noise level, to a variety of conditions caused by travel requirements such as customer offices, research labs, hospitals, hotels, use of automobiles, commercial travel, weather, etc.
Physical Demands:
Activities require a significant amount of sitting in front of a computer monitor, some standing and walking. Significant use of hands and arms, plus finger dexterity to reach, point, write, type, operate a computer and other office equipment. Performs tasks that regularly require good correctable vision and hand/eye coordination. Activities also require significant use of voice and hearing for discussions with other employees.
General Qualifications:
Bachelor’s degree in a technical discipline or equivalent experience
10+ years of technical system administration experience
10+ years of experience translating business requirements into technical designs
At least 3 years’ experience working in regulated environments
At least 3 years’ experience working with enterprise LIMS/LIS, ELN, LES, SDMS and/or CDS systems or implementations
Excellent communication and customer service skills. Able to bridge communication between technical areas and business areas for a full and complete understanding of expectations
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to travel approximately 10%, including internationally