Job Description · Actual Title of the role: Sr TrackWise Consultant · Duration: 1 Year · Contract/possibility for conversions: Contract · Max Pay rate: 88/hr. · Onsite/Hybrid/Remote: Hybrid · Only Locals/Nonlocals can be submitted: Should be on-site in Sunnyvale · Mode of interview: Virtual/In-person · No of rounds of interview: 2 Top Skills: · TrackWise Configuration · TrackWise Web Service Development · TrackWise Crystal Reports Development · Strong knowledge and experience in Java programming, 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 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 Requirements Spotlight Call Notes: Intuitive Surgical Req#ISIJP00012161 Sr. TrackWise Consultant HM: Pradeep Reddy Sudireddy Pay Rate: $88/HR W2 Locations: Sunnyvale, CA (Hybrid) Project Duration: 12 Months Contract No of Position: 1 Interview Process: 2 Rounds (both Technical - Deep technical assessment on: TrackWise configuration, Troubleshooting scenarios, Java / web services understanding, Possible live coding or design-style questions - Especially to verify candidates who say they did Java “long ago.”) This is TrackWise Techno-Functional role, someone who can independently support, troubleshoot, configure, and enhance an existing enterprise TrackWise environment while also understanding the Java code behind the application. The role is heavily focused on production support, analysis, and configuration, with a smaller but important development component. Please note: We do not need someone to build a new TrackWise implementation from scratch. Instead, we need someone who can walk into an existing production environment and immediately become the "go-to" TrackWise expert onsite. Skills Required: 8–15 years of IT experience 6–10+ years of dedicated TrackWise experience Strong production support background Hands-on TrackWise configuration experience Java development experience (current or previous) Web Services experience Crystal Reports experience Pharma or Medical Device industry background Experience supporting regulated Quality Systems Strong business communication skills Comfortable working independently Technical Screening Questions: How many years of hands-on TrackWise configuration experience do you have? Which TrackWise components have you configured (workflows, screens, forms, business rules, notifications)? Can you describe the most complex TrackWise issue you resolved in a production environment? Have you supported a live production TrackWise environment? What kinds of incidents did you handle? How recently have you worked with Java? Are you comfortable reading and debugging Java code today? Have you developed or debugged Java-based TrackWise web services? Can you describe a specific example? Have you integrated TrackWise with other enterprise applications, such as SAP? Describe a time when you worked directly with business users to gather requirements and translate them into a TrackWise solution. Have you collaborated with offshore development teams? How did you coordinate issue resolution across time zones? Which regulated industries have you worked in (Medical Device, Pharma, Biotech)? How has your work been influenced by 21 CFR Part 11 or GxP requirements? Have you used AI coding tools such as GitHub Copilot or ChatGPT to assist with Java development or code reviews? How did you validate the generated code? This is a long-term contract supporting production systems. Are you comfortable with that type of engagement?
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