01 Nov
|
Intuitive
|
Bengaluru
01 Nov
Intuitive
Bengaluru
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 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.
The Business Systems and Change Analyst is responsible for processing change orders and successfully implementing system and processes improvements in the Document Control department. The position represents Document Control department in projects and collaborates with cross-functional departments, ensuring Compliance with Intuitive Document Control Standards and Regulatory requirements. Work closely with the senior Business and Systems Process Analysts to draft and review requirements, test scripts and execute PLM system and process updates. This position reports directly to the Senior Manager, Document Control.
Execute improvement activities for the PLM system (Agile) and Document Control Processes
Represent Document Control during requirements definition phase of projects
Participate in planning sessions for approved projects to provide input to requirements
Participate in multiple project teams. Work with business owners to ensure the team understands users' business activities and that the acceptance criteria are defined.
Create test scripts related to PLM and Document Control projects. Execute User Acceptance testing.
Work with Computer System Validation (CSV) groups in Regulatory and IT to ensure project compliance with regulatory and Intuitive CSV policies and procedures
Identify and resolve project issues and manage project dependencies within the Document Control environment to keep the critical path on track.
Update impacted procedures and ensure all required documentation is updated and released at the time of project implementation
Support and Contribute to the Agile Training Forum. Provide input to slide content related to processes and PLM system questions.
Review and assess Document Control tickets to understand issue details and requirements. Resolve the complex Document Control tickets.
Become embedded in the process – spend a portion of time processing ECOs and responding to internal customer issues
Support the Senior System and Business Analyst on assigned tasks and projects
Process a daily quota of change orders to support the business
Audit documentation changes for accuracy, completeness, and compliance with language, procedural, and regulatory requirements.
Ensure changes are in a closed loop with all discrepancies addressed before release, where analysis of situations or data requires knowledge of regulatory and change control principles.
Maintain data integrity within Agile form fields and update item forms within Agile to accommodate changes within company processes and requirements
Have in-depth Agile system and change control processes knowledge in order to troubleshoot issues as needed and know when to escalate them to IT
Understand how Agile links to other systems within and outside Intuitive. Provide support on Agile integration-related requests.
Update Document and Change Control procedures as needed
Required Skills And Experience
Experience in a Regulatory/Quality organization in a medical device company
Experience with and knowledge of both the functional and technical aspects of a PLM system,
Agile preferred
knowledge of Change Control principles for Document Control and IT systems
Experience working on process and system improvement projects
Working knowledge of Microsoft Office products (MS Word, MS Excel, MS Visio)
Planning and organizing adaptability; ability to react to project adjustments & alterations promptly and efficiently
Experience working with 5+ person cross-functional project teams
Ability to communicate clearly and effectively to both business stakeholders and technical team members (e.g. IT)
Self-starter, able to work with minimal supervision
Required Education and Training
University degree with a minimum of 6-10 years of equivalent work experience.
Quality System Regulations and ISO requirements Training
Project Management Training
Quality Systems Validation Training
Working Conditions (As applicable - This role requires sedentary and repetitive working conditions, some overtime required. 15% travel)
Preferred Skills And Experience
Project Management
Medical Devices
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.
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 adaptable, and within a timeframe that does not unreasonably impede the hiring need. business need and/or on the selected candidate's experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
Shift: Day
📌 IT Business & Process Analyst (Bengaluru)
🏢 Intuitive
📍 Bengaluru