Solution Architect IT Business Applications
Solution Architect IT Business Applications
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Salary Not Disclosed
1 Vacancy
Job Description
Primary Function of the Position
The 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 postmarket 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 crossfunctional 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 companys IT strategy and longterm business objectives.
- Project Leadership & Collaboration:
- Collaborate with crossfunctional 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 thirdparty 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.
Qualifications :
Required Skills and Experience
- Indepth 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 handson experience with ERP QMS and RIM system integrations.
- Strong problemsolving 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 largescale IT solution implementations.
Required Education and Training
- Bachelors degree in engineering computer science or associated technical degree.
Preferred Skills and Experience
- Minimum of 810 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.
- Handson 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 COVID19. Details can vary by role.
Intuitive is an Equal Opportunity 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.
Mandatory Notices
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 marketcompetitive 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.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
