Information Systems Engineer 3

DGN Technologies; Sunnyvale (CA); On-site; USD 120,000 - 150,000; Full time

Job summary

DGN Technologies is seeking a skilled TrackWise Systems Analyst to identify, develop, and implement software solutions that improve process effectiveness and efficiency. You will manage projects and software throughout their lifecycles, work with process owners, and ensure regulatory compliance.

Responsibilities include analyzing and configuring IT business systems, creating detailed specifications, and training users on new configurations.

Qualifications

• Minimum 8 years of TrackWise System Analysis experience, including requirements gathering, design and validation support.
• Experience analyzing, configuring, modifying and implementing IT business systems.
• Familiarity with regulatory requirements (21 CFR Part 11, GxP) and CAPA/Complaints processes.

Responsibilities

• Participate in analysis, configuration, modification and implementation of IT Business Systems.
• Communicate clearly to help identify and resolve system issues to maximize benefits.
• Analyze existing processes and propose solutions using standards and best practices.
• Create detailed specifications and process flows for developers.
• Design solutions, define requirements, and test IT solutions.
• Train users on new configurations and maintain system integrity.
• Coordinate with onsite/offshore teams and managers to release high-quality solutions.
• Ensure compliance with change control processes.

Skills

TrackWise System Analysis

Crystal Reports

SDLC knowledge

Tools

SAP integration

TrackWise WebServices (OWS/IWS)

Job description

Detailed Job description:

Position Overview:

Person will be responsible for identifying, developing and implementing software solutions. This will include working with process owners to identify continuous improvement opportunities and develop software solutions to support process effectiveness and efficiencies. Individual will also be accountable for managing projects and software throughout their respective lifecycles.

Roles and Responsibilities:

• Directly participate in the analysis, configuration, modifying and implementation of IT Business Systems
• Demonstrate good communication, analytical and problem-solving skills to help identify, communicate and resolve system issues in order to maximize the benefit of IT systems
• Analyze the effectiveness and efficiency of existing business processes and business requests, and recommend solutions using system standards and best practices
• Conduct analysis of system specifications, configurations and develop appropriate documentation
• Create detailed specifications and process flows to provide direction to application developers
• Perform solution designing, requirements definition, functional design, testing and implementation of IT solutions
• Support, assist and train the users on new modified system configurations highlighting the impact on business processes
• Maintain IT Business system integrity and application notes, system upgrades, changes, and user updates
• Work closely with onsite team, off shore team, managers and executives to ensure the release of high quality solutions
• Comply with regulatory and change control requirements and processes

Skill/Job Requirements:

• Minimum 8 years of TrackWise System Analysis experience Perform business requirements gathering, requirements analysis, business system design, installation, configuration, user testing and validation support of TrackWise based applications Create workflows, Business rules, TWC automation, Notifications and Migrate updates Create TrackWise WebServices (Search/Populate/Transfer) using OWS/IWS.
• Create and Implement Crystal Reports

Experience:

• Experience in Medical Device manufacturing industry and systems regulations (21 CFR Part 11, GxP, GAMP, etc.)
• Knowledge and good understanding of CAPA and Complaints processes
• Exposure to integration with SAP systems preferred
• Experience on TrackWise Quality View is preferred
• Experience working with business end users, gathering requirements and building detailed functional design specifications
• Ability to work on multiple projects concurrently
• Ability to work with minimum supervision or guidance
• Familiarity with Software Development Lifecycle (SDLC) processes
• Good verbal and written communication skills
• Should contribute in team building measures like Knowledge Management & Mentoring