Post Market Surveillance (PMS), Business Systems Architect

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.

Mandatory Notices

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 employeeswho 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 governments 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 employeesstart 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.

Remote Work :

No

Employment Type :

Full-time