Solution Architect, IT Business Applications

Company: Intuitive
Location: Sunnyvale
Posted on: April 6, 2025

Job Description:

Job DescriptionPrimary Function of the PositionThe individual in this role will be reporting to the IT Business Applications Director or Senior Manager.The IT Solutions Business Systems Analyst / Architect for Enterprise Learning Technologies is responsible for assessing, selecting, designing, developing, and overseeing the implementation of scalable and compliant IT solutions that support the entire product lifecycle, from design and development to post-market activities. This role focuses on ensuring systems are optimized to support the Enterprise Learning Management domain in a medical device manufacturing environment.The BSA / architect will work closely with cross-functional teams, including within the Enterprise Learning business and IT, to ensure solutions align with business goals, regulatory requirements, and industry best practices.This position will coach and manage a team of proposed developers and analysts that support the user community, develop, test, and deploy state of the art solutions with the help of vendor developed solutions.Essential Job Duties

• Solution Design & Architecture:

• Lead the design and development of IT solutions for Enterprise Learning processes, ensuring scalability, compliance, and alignment with medical device regulations (FDA, ISO, MDR, etc.).
• Develop architecture blueprints for the Learning system, integrating with other critical systems such as ERP, PLM, Access Management and other related tools.
• Ensure alignment of system architecture with the company's IT strategy and long-term business objectives.
• Project Leadership & Collaboration:
  • Collaborate with cross-functional teams including R&D, Commercial, Regulatory Affairs, Quality Assurance, Engineering and Manufacturing to gather business requirements and translate them into IT solutions.
  • Lead solution development projects, ensuring timely delivery, compliance with GxP standards, and adherence to project budgets.
  • Manage vendor relationships, including evaluation of third-party solutions, software customization, and system integration efforts.
  • System Integration & Customization:
    • Design and oversee integration between Enterprise Learning platforms (such as SuccessFactors, ComplianceWire, CornerStone) and other enterprise systems (ERP, QMS, PLM, Workday, etc.).
    • Lead efforts to customize the LMS to meet specific needs, including managing system upgrades and migrations.
    • Regulatory Compliance & Validation:
      • Ensure that all IT solutions are compliant with relevant regulatory frameworks, including FDA 21 CFR Part 11, ISO 13485, and EU MDR, and are GxP validated where required.
      • Collaborate with validation teams to document system specifications, design qualifications, and test protocols in alignment with regulatory standards.
      • Continuous Improvement & Innovation:
        • Stay up to date with industry trends and advancements in Learning technologies, recommending innovative solutions to optimize product lifecycle processes.
        • Lead continuous improvement initiatives, ensuring that solutions are adaptable to evolving regulatory requirements and business needs.
        • Support & Troubleshooting:
          • Provide advanced technical support for LMS systems, troubleshooting complex issues, and coordinating with internal and external teams to resolve problems.
          • Act as the subject matter expert for LMS systems, providing training and guidance to business users and junior IT staff.
          • This role requires working onsite in our Sunnyvale, CA, office Tuesday, Wednesday, and Thursday every week.
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Keywords: Intuitive, Carmichael , Solution Architect, IT Business Applications, Other , Sunnyvale, California