Systems Analyst, Mfg

Job Summary

The Systems Analyst, Manufacturing will work cross-functionally as a member of the TMC IT Team supporting the IT systems for Engineering, Quality and Manufacturing Operations. This role will provide primary support for the implementation, configuration, maintenance, and continuous improvement of software applications intended to deploy our Factory of the Future, while maintaining regulatory and compliance requirements in the design and manufacture of medical devices. The Systems Analyst, Manufacturing will drive positive changes in technology while supporting the cultural transition from manual to automated processes.

Job Details/Responsibilities

• Analyze, administer and support current and new IT solutions.
• Support project teams by developing, deploying, and supporting applications. 
• Analyze current business processes then document, recommend and help implement solutions that deliver value realization.
• When developing conceptual data models, align business goals with data structures and ensure data models accurately identify key business entities (e.g., customers, products, or departments) and their relationships as well as the data flow from data collection to processing and storage always ensuring the right data will be available for decision-making.
• Employ industry and IT systems best practices. 
• Review system modifications for cross-compatibility and integration.
• Perform gap analysis and recommend alignment.
• Develop and perform testing for software validation, including integration testing and unit testing.
• Possess working knowledge of quality processes and controls.
• Develop and deliver training to end users regarding functionality of applications.  
• Troubleshoot and optimize processes for IT systems for operations. 
• Assist with the execution of projects, installations, upgrades, and revisions from design through deployment.
• Support database activities and schedules.
• Lead and/or support corrective actions related to nonconformances found within processes.
• Perform other job-related duties as assigned.

Knowledge, Skills and Abilities (KSA)

• Analytical ability to elicit business requirements and translate into technical specifications preferred.
• Strong troubleshooting and problem-solving skills required (to resolve application issues efficiently and effectively).
• Ability to manage all project phases ensuring stage gates and delivery dates are successfully achieved.
• Excellent verbal and written communication skills to effectively interact with all stakeholders, from leaders to end-users.
• Ability to create and maintain documentation such as user guides, SOPs, and validation protocols.
• Proficient with Microsoft office applications.
• Deep understanding of mathematics and statistical analysis.
• Ability to train end-users on applications and systems.
• Refined organizational skills and attention to detail lead to accurate and thorough task completion.
• Collaborative and effective contributor in cross-functional teams.
• Adaptable and flexible by staying current with industry trends and technological advancements.
• Strongly focused upon regulatory compliance and quality standards.
• Logical and critical thinker, solving complex problems and making informed decisions.
• Understanding of physical and relational data models.
• Effective initiator of communications and collaborations with stakeholders, including business requirements elicitation and translation into technical specifications.
• Understanding our work (all that we do) must result in value realization.
• Troubleshoot and resolve application issues, providing timely support to end-users.
• Develop and maintain documentation, including user guides, SOPs, and validation protocols.
• Ability to support requests raised in regulatory inspections to ensure ongoing compliance.
• Willingness to enhance understanding and utilization of applications by providing training and support.
• Maintain the curiosity required to stay current with industry trends and advancements in technology to recommend improvements and innovations.
• Ability to support end users and provide technical assistance remotely and locally.

Qualifications/ Background Experiences

• Bachelor’s degree in Computer Science, Information Technology or a related field (or an equivalent combination of education and experience) required or equivalent work experience.
• Minimum of 2 years of experience in an IT role supporting Manufacturing Operations/Supply Chain (or an equivalent combination of experience in a non-IT role with hands-on use of Manufacturing, Quality, Enterprise Asset and/or Warehouse systems) required.
• Software implementation experience required.
• Experience in medical device manufacturing and knowledge of GxP compliance and FDA process validations, including development and execution of protocols is a plus.
• Experience in Manufacturing and Supply Chain processes and systems preferred, specifically with Enterprise Resource Planning (ERP), Manufacturing Execution Systems (MES), Quality Management Systems (QMS), Warehouse Management Systems (WMS), Automated Storage & Retrieval Systems (ASRS), Automated Guided Vehicles (AGVs) and their interfaces.  
• Certifications in Certified Information Systems Security Professional (CISSP), Project Management Professional (PMP), Certified in Production and Inventory Management (CPIM), Certified Quality Auditor (CQA), ITIL Foundation Certification, IIBA Certified Business Analyst Professional (CBAP), Lean Bronze Certification, Lean Silver Certification, Lean Gold Certification, Six Sigma Black Belt, Six Sigma Green Belt, any ASCM Supply Chain Certification preferred.