Company Description
Job Description
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.
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 USD - $250,800 USD
Base Salary Range Region 2: $148,100 USD - $213,100 USD
Shift: Day
Workplace Type: Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.
