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Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry.

TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients.

TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $5 billion in sales, 20,000 employees worldwide and operations in more than 160 nations.

Terumo Medical Corporation is comprised of two strategic business divisions : Terumo Interventional Systems and Terumo Medical Products.

Job Summary

Under the leadership and guidance from the Manager of TMC Manufacturing IT, the Application Specialist I role will collaborate with the business, TAH Center of Excellence (COE), manufacturing and quality stakeholders, in the design, configuration, coding, validation, deployment and support of TMC Manufacturing and Quality applications.

This position is a key role in the continuous improvement of processes & information systems which enable high quality medical devices to reach patients safely and efficiently.

Job Details / Responsibilities

Design, Implementation and Support of Manufacturing and Quality Applications :

Collaborate with SAP COE Team, TMC Operations, and TMC Quality to develop and maintain roadmaps for the effective and efficient use of Manufacturing, Production Execution and Quality Management solutions.

Effectively communicate and collaborate with the SAP COE Team and TMC Stakeholders to address application specific configuration, coding, and multi-system integration to support desired business outcomes.

Requirements gathering, design, configuration, coding, and support of new and existing TMC Manufacturing and Quality applications.

Assist with all installation, testing, and validation efforts related to FDA CFR Part 11 Software Validation.

Provide application administration support of custom, commercial-off-the-shelf (COTS) software, user permissions, security settings, and workflow for internal and customer-facing applications.

Respond to Help Desk tickets for timely resolution of service requests.

Work with vendor support to debug and determine fixes for identified software defects.

Provide documentation and how-to guides for triage and first call resolution goals.

Provide technical support to TMC Engineering, Quality and Operational Technology lead initiatives.

Engage and assist in the integration of factory floor and automation systems with Quality and Operational systems.

Provide root cause analysis, corrective and preventative actions for any IT service disruptions.

Analyze and reduce recurring Help Desk calls / issues.

Comply with environment, security, health and safety requirements.

Installation, tuning and support of both Oracle and MS-SQL databases.

Establishing and maintaining excellent relationships with key external stakeholders

Perform other job related duties as assigned.

Knowledge, Skills and Abilities (KSA)

• Proficient with writing SQL query scripting and debugging SQL statements required.
• Working knowledge of web services protocols (SOAP and REST).
• Working knowledge of FDA CFR Part 11 Software Validation processes.
• Working knowledge of C#, HTML, Javascript, JSON and other object-oriented languages as well as working knowledge of Application Lifecycle Management tools (HP ALM) preferred.
• Strong communication (verbal and written), effective listening, and collaboration skills.
• Ability to adapt to continuously changing demands / priorities.
• Strong desire to learn new skills / techniques / processes.

Qualifications / Background Experiences

• changing demands / priorities.
• Strong desire to learn new skills / techniques / processes.

Background Experiences

Associate degree in any process area (e.g., IT, Finance, Supply Chain, etc.) and 6 years related Application Support experience.

Bachelorâ  s degree preferred.

• Experience in developing and turning efficient database transactions for ORACLE and MS-SQL.
• Experience with the latest LAN / WAN network topologies and architecture.
• Experience with Camstar Manufacturing Execution System and experience with an electronic quality management system preferred.
• Experience with Vaisala Environmental Monitoring Solution, TMS Quality Compliance Software, or IBM Maximo software and software version control (git, TFS, Azure DevOps or equivalent) a plus.
• Experience with integration technologies (SAP PI / PO, Camstar CIO) or platforms a plus.
• Some travel (up to 20%)

It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law.

As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.

Last updated : 2024-03-29