Demo

Solution Architect, IT Business Application - Future Opportunity

Intuitive Surgical
Sunnyvale, CA Full Time
POSTED ON 2/27/2025
AVAILABLE BEFORE 5/21/2025

Company Description

At Intuitive, we are united behind our mission : we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

The individual in this role will be reporting to the IT Business Applications Director or Senior Manager.

The  Solution 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 Solution 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, and 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 office on Tuesday, Wednesday, and Thursday every week.
  • Qualifications

    Required Skills and Experience

    In-depth knowledge of cloud-based systems in the Medical Device / Pharma / Lifescience industries in a highly regulated environment.

  • Strong understanding of medical device regulations, including FDA 21 CFR Part 820, ISO 13485, and EU MDR.
  • Expertise in system integration, including hands-on experience with ERP, QMS, and RIM system integrations.
  • Strong problem-solving skills, with the ability to troubleshoot and resolve complex system issues.
  • Proficiency and certification in enterprise architecture methodologies and frameworks (e.g., TOGAF, Zachman).
  • Project management skills, with experience managing large-scale IT solution implementations.
  • Required Education and Training

  • Bachelor’s degree in engineering, computer science, or associated technical degree.
  • Preferred Skills and Experience

    Minimum of 8-10 years of experience in IT, with at least 5 years in a solutions architect role, specifically within the medical device or pharmaceutical industry.

  • Proven track record of designing and implementing PLM systems such as Oracle Agile PLM, PTC Windchill, or Siemens Teamcenter.
  • Experience with regulatory and quality management systems (RIM, QMS) like Veeva, Trackwise, and knowledge of GxP validation processes.
  • Hands-on experience with system integrations, software upgrades, and customization of enterprise systems.
  • Additional Information

    Due to the nature of our business and the role, please note that Intuitive and / or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

    Intuitive is an Equal Employment Opportunity / Affirmative Action Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

    EEO and AA Policy

    We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

    Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

    We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.

    Base Salary Range Region 1 : $174,300 - $250,800

    Base Salary Range Region 2 : $148,100 - $213,100

    Shift : Day

    Travel : None

    Workplace Type : Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.

    Salary : $148,100 - $250,800

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