Senior TrackWise Consultant

***Please note that our customer is currently not considering applicants from the following locations: Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, and Tennessee.***

Our Customer is a corporation that develops, manufactures, and markets robotic products designed to improve clinical outcomes of patients through minimally invasive surgery. Founded in 1995, their goal was to create innovative, robotic-assisted systems that help empower doctors and hospitals to make surgery less invasive than an open approach. Working with the top medical professionals, they continue to develop new, minimally invasive surgical platforms and future diagnostic tools to help solve complex healthcare challenges around the world.

We are seeking a Senior TrackWise Consultant on a contract basis to support our Customer's business needs. This role is hybrid in Sunnyvale, CA.

Role 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.

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.

Skills & Qualifications:

• TrackWise Configuration
• TrackWise Web Service Development
• TrackWise Crystal Reports Development
• Strong knowledge and experience in Java programming
• 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

We offer a competitive salary range for this position. Most candidates who join our team are hired at the median of this range, ensuring fair and equitable compensation based on experience and qualifications.

Contractor benefits are available through our 3rd Party Employer of Record (Available upon completion of waiting period for eligible engagements) Benefits include: Medical, Dental, Vision, 401k.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.