Post Market Surveillance (PMS), Business Systems Architect
- Full-time
- Shift: Day
- Max. Salary Region 2: 196600 USD
- Max. Salary Region 1: 231300 USD
- Ways of Working: Purposeful Onsite - This job requires being onsite for leader-defined events and activities which could be monthly/annually. Onsite frequency may increase based on business need.
- Employee Type: Employee
- Global Job Level (HCM): Professional 4 (11)
- Min. Salary Region 1: 160700 USD
- Min. Salary Region 2: 136600 USD
Company Description
It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.
We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.
The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.
If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.
Job Description
Primary Function of Position (Brief statement (3-5 sentences) describing the reporting structure, main responsibility(s) and key function(s) which will contribute to the overall success of the individual in this job)
PMS Business Systems Architect will report to PMS Operations Manager. This role will be responsible for identifying, analyzing, refining, translating, and finally documenting business requirements related to the Complaint eQMS System. This role will ensure business requirements are accurately developed and tested through authoring and executing test scripts. This role will work closely with global PMS business users and IT solution team to ensure business needs and projects are delivered. In addition, the PMS Business Systems Architect will triage day-to-day Complaint eQMS System technical support before escalating to the IT team.
Essential Job Duties (Specific responsibilities and tasks an individual would be expected to perform in the role. Additional job duties may be determined by functional people manager)
Assists with the review of business case documents, project plans and schedules to ensure business needs are met.
Facilitate sessions with all relevant stakeholders to drive clarity and agreement on requirements.
Documentation of requirements, authoring & execution of test cases and change management procedures for existing critical eQMS Complaint systems ensuring change meets (or exceeds) business objectives.
Reviews, updates and develops documentation including but not limited to requirements, process workflows, user requirements, use cases, data mapping/validations, business rules, test scripts, and procedures for future references.
Develops and describes a sufficiently deep and comprehensive understanding of both, the PMS business processes/objectives/outcomes and technology solutions and uses that knowledge to propose and guide business improvements.
Performs mass update of Complaint eQMS records to process high volume of records.
Triage day-to-day Complaint eQMS System technical support before escalating to the IT team such as troubleshooting FDA MDR Submission failures, complaint system integrations errors
Performs other duties as assigned.
Qualifications
Required Skills and Experience (Specific skills, knowledge, and experience that an individual must possess in order to successfully perform in job)
Strong understanding of the global PMS business process.
Understanding of the Software Development Life Cycle.
Outstanding analytical skills and proven track record of utilizing team-based approach to quickly and accurately resolve system/solution issues.
Strong business analysis and project management skills.
Strong communication and writing skills on a business and technical level.
Demonstrated skills in solution development and implementation from a business owner perspective.
Strong skills in documentation for business and technology user audiences.
Strong technical background and ability to effectively balance multiple priorities.
Strong understanding of system development, IT and business process and their inter-relationship.
Proven creative problem solver with ability to work effectively in a hyper-changing environment.
Capable of working autonomously, responsibly, and reliable under a non-direct reporting structure in a fast paced and constantly changing environment.
Required Education and Training (As applicable - Specific education and training that an individual must possess in order to successfully perform in job)
Minimum 5yrs of medical-device or pharmaceutical life-science industry GxP system validation experience
Minimum 10 years of experience in gathering and defining business requirements, analyzing/mapping business processes, supporting the design, development, implementation, and maintenance of business-driven technical solutions and applications, with a proven track record of increasing responsibility
Minimum 10 years of experience working with TrackWise and other eQMS applications
Bachelors Degree
Working Conditions (As applicable - Any physical requirements for the job. If not applicable, state “none”)
None
Preferred Skills and Experience (As applicable - Specific skills, knowledge, and experience that are not required to perform the job, but are desirable to have)
-
Strongly Preferred:
Minimum 5-year experience with TrackWise, SAP ERP, SAP CRM, and Salesforce
Minimum 5-year experience with software validation testing tools (such as HP ALM, qTEST) testing experience
Preferred (nice-to-have):
Experience with LucidChart, Visio, Excel, Smartsheet
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 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.
U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).
For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.
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 compensation ranges are listed.