Post Market Surveillance (PMS), Business Systems Architect

Intuitive • Sunnyvale, CA

19h

About The Position

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. 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.

Requirements

• 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.
• 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

Nice To Haves

• 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

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level