Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.
The IT Analyst - Business Applications Support role will be responsible for the documentation of functional business application requirements and change control compliance for In-Scope/Key business applications including, but not limited to: ERP, Purchasing Requisition System, Doc Control System, and the Data warehouse.
The ideal candidate will be detail oriented, familiar with project management and compliance documentation methodologies, and will possess IT skills specific to testing application functionality and data verification tasks. This role will work closely with functional leaders, organizational units, and subject matter experts to identify, document, track, map, and deploy new business processes within key applications. This role is part project manager, part administrator, part IT Compliance Documentation Specialist and Part IT Client Services (Helpdesk activities). This role will be responsible for ensuring that all compliance requirements are met before any changes are made to key applications (i.e. apps under change control).
Essential Job Functions
Support IT compliance requirements related FDA, SOX, GDPR, CCPA, Security, and software licensing
Document and maintain IT policies and procedures with strong focus on compliance and security
Serve as primary user and security group administrator for QAD including evidence of approvals
Complete regular internal system audits as it pertains to AD, Linux, software licensing, and In Scope/Key data & applications
Provide project management and create/maintain documentation for all projects under change control
Coordinate the evaluation, scope, testing, approval and completion of new development requests
Work with management team to establish suitable business processes to support administrative, development, and change management activities
Effectively act as the liaison between our users, vendors and the application development teams
Work independently with members of the user community to define and document both current state and ongoing development requirements
Assist with Helpdesk activities and other IT functions as needed
BS or BA preferred or equivalent experience (7-10 years IT Experience).
Minimum five (5) years of experience in IT Administrator/Applications Support role
Must possess strong customer service skills
Proven ability to document, test and implement new processes
Strong document management abilities (Word, Excel, PowerPoint, PDF, etc.)
Experience with FDA and SOX regulated environments desirable
Previous experience working in a SCRUM or agile environment desirable
Familiarity with Cybersecurity tools, investigations and reporting desirable
Written and verbal communication skills to communicate effectively at all levels.
Ability to work in a fast-paced environment while managing multiple priorities
Operate as a team and/or independently while demonstrating flexibility to changing requirements.
Shockwave Medical offers a competitive total compensation package including comprehensive benefits (medical, dental, vision) as well as pet insurance and student loan refinancing support.
Shockwave Medical, Inc.