Cook Medical · 6 hours ago
System Analyst II
Pittsburgh, PA
Full-time
Hybrid
Entry, Mid Level
1+ years expCook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine, focusing on the treatment of several muscle-related disorders. The System Analyst II provides technical expertise and operational ownership of applications and business intelligence solutions, ensuring user requirements are met and supporting the delivery of these solutions.
HardwareManufacturingMedical Device
Responsibilities
Serve as platform owner for applications and/or business intelligence solutions for the duration of a Systems Development Lifecycle (SDLC); has responsibility for the delivery, integration, modification, maintenance, and retirement of the application and/or business intelligence solution
Work with business analysts and departmental system owners to define technical project scope and the user requirements specification for a proposed solution
For new / updated applications and/or business intelligence solutions; authors application functional specifications, configuration and data mapping documents, and commissioning documents (i.e. unit tests, software verification tests)
Support the delivery of applications and/or business intelligence solutions by either configuration of parameters and workflows to define behavior, and/or programming (i.e. C#, SQL, Python, etc.) to extend capabilities
Lead solution demonstrations and works with departmental system owners’ and end-users to ensure user requirements are met
Actively participate in validation risk assessments and various reviews meetings supporting solution delivery
Execute commissioning; supports computer system validation team’s installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities as needed
Function as a system administrator and/or data administrator
Develop reporting tools to support quality, including configuration to support data trending and analysis
Ensure data integrity by monitoring system performance, security, and data metrics
Create and review Standard Operating Procedures (SOPs) and training materials; conducts training for SOPs
Practice and stays current with ISPE GAMP best practices, FDA GxP regulations, and applicable ISO standards
Coordinate activities with external consultants
Monitor project progress by tracking activities; resolving problems; publishing progress reports; recommending actions
Qualification
Required
Undergraduate degree in Computer Science, Engineering, Information Systems, Business Systems, or 6 years direct, relevant experience in development, delivery, and support of enterprise-wide computerized system solutions to provide a comparable background
Advanced proficiency in MS Office, specifically, advanced knowledge of Project, Adobe, OneNote, Excel, Word and PowerPoint; Expert in Outlook
Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing
Ability to learn and support new systems and applications, and the ability to provide technical training to end users
Minimum of 1-3 years' experience in one or more of Applications Engineering or Configuration, Application Delivery, Software Development, Data Warehouse Development, Software Requirements Analysis, Information Analysis, or Software/IT Support
Minimum of 1-3 years' experience with packaged software tools (MATLAB, LabView, solidThinking, etc.) or programming languages (C, C++, C#, SQL, Python, Java, JS, etc.) or traditional statistical software tools (e.g. JMP, SAS, R, Minitab)
Exemplifies Cook MyoSite Core Values
Maintain regular and punctual attendance
Must maintain company quality and safety standards
This position requires an ongoing commitment to upgrading knowledge, job skills and abilities in addition to competency related to all duties and responsibilities listed above
Ability to work in collaborative and independent work situations and environments with minimal supervision
Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability
Must work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goals
Trainability
Must have effective verbal, written and interpersonal skills
Able to prioritize and operate proactively
Experience in developing solutions in enterprise class IT systems (i.e. ERP, eQMS, HRIS, SSRS, Qlik, CRM, etc.)
Experience delivering and/or supporting CRM, eCommerce, websites, or content management systems
Experience working in a highly regulated environment (Pharmaceutical, Medical Devices, Financial)
Company
Cook Medical
Cook Medical is a medical device company that specializes in designing, manufacturing, and delivering invasive medical devices. It is a sub-organization of Cook Group.
10001+ employees
H1B Sponsorship
Cook Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2023 (3)
2022 (2)
Funding
Current Stage
Late StageLeadership Team
G
Gayle Cook
Co-founder
Kelly Fischer
Senior Vice President and Chief Financial Officer
Recent News
Company data provided by crunchbase