TMC Enterprise Architect

Date:  Apr 3, 2025
Req ID:  4623
Location: 

Elkton, MD, US

Company:  Terumo Medical Corporation
Department:  TMC Information Technology

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 $6+ billion in sales, 30,000+ 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.

We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.

At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.

Join us and help shape wherever we go next!

Advancing healthcare with heart

 

 

 

 

Job Summary

The TMC Enterprise Architect will own the execution of the IT strategy and roadmap that supports the enterprise vision and mission. In addition, the IT solutions will enable achievement of business goals and regulatory compliance in the design and manufacture of medical devices within the Manufacturing and Distribution Locations at TMC. This role works cross-functionally to drive technical change and cultural transition by automating processes intended to deploy our Factory of the Future.

Job Details/Responsibilities

  1. Own and implement a strategic IT roadmap that aligns with the organization’s prioritized business objectives and includes plans for existing and future IT solutions that deliver value realization.
  2. Facilitate cross-functional roadmap review meetings to ensure changes in business prioritization are accurately reflected and roadmap stage gates and milestones are compatible with other business and IT objectives.
  3. Establish and enforce enterprise-wide IT standards to promote the correct and consistent use of technologies within the organization.
  4. Identify, assess, and mitigate potential risks associated with IT investments.
  5. Analyze requirements, develop designs and production migration procedures and oversee the implementation of business applications and services.
  6. Create a comprehensive plan and structured approach to implement end-to-end factory automation including machine integration that minimizes the number of Operator keystrokes and resulting human errors and increases throughput while ensuring electronic Device History Records (eDHR) meet quality standards and regulatory guidelines.
  7. Lead the design and implementation of enterprise solutions such as ETQ Quality Management System (QMS) and a Laboratory Information Management System (LIMS) as well as related integrations. 
  8. Provide technical mentorship to developing IT members supporting ETQ and LIMS as well as Enterprise Resource Planning (ERP), Manufacturing Execution Systems (MES), Warehouse Management Systems (WMS), Continuous Monitoring Systems for Controlled Environments, Automated Storage & Retrieval Systems (ASRS), Automated Guided Vehicles (AGVs) in addition to their interfaces.  
  9. Provide specifications for the acquisition of tools, as needed.
  10. Work with internal/external customers to solve technical challenges using industry best practices.
  11. Design application architecture, including user interface and middleware; collaborate with the IT Infrastructure team.
  12. Lead the creation and review of design documents and artifacts; facilitate code reviews.
  13. Collaborate with key Stakeholders to ensure Architecture is aligned with Stakeholder requirements as well as Business Requirements.
  14. Demonstrate application prototypes and integrate user feedback.
  15. Oversee application maintenance, upgrades, and migration.
  16. Document application development processes, procedures, and standards.
  17. Remain abreast of the latest technologies and trends; stay ahead of the curve and ensure continuous IT improvement and modernization.

Knowledge, Skills and Abilities (KSA)

  • Takes accountability for results and drives project to the completion on time and within budget.
  • Proficient at developing and maintaining precise system documentation, guidelines, and presentations for management review.
  • Experience analyzing enterprise system performance using process improvement methodology.
  • Participates in development activities including code reviews, as well as coding and testing of new enhancements.
  • Proficient with MSWord, Excel and Power Point office applications. 
  • Demonstrate and model effective listening, sound logical judgment, and organizational skills.
  • Excellent communication skills both verbal and written are required to partner with and update key stakeholders on a frequent basis. 
  • Demonstrate strong knowledge of mathematics and statistical analysis.
  • Firsthand experience with physical and relational data models.
  • Demonstrate and model troubleshooting skills.
  • Knowledge of GAMP5 Methodology preferred but not required.
  • Knowledge of FDA process validations, including development of protocols and execution of protocols and GXP.
  • Ability to support end users remotely and locally and provide training and technical assistance when required.
     

Qualifications/ Background Experiences

 Minimum Bachelor’s Degree in Computer Science or IT required, or equivalent combination of education and experience.

  • A minimum of ten (10) years’ experience supporting manufacturing systems including MES and  integrations with ERP and other systems required. 
  • A minimum of five (5) years’ experience as an IT Architect with experience designing, developing and implementing complex IT solutions that drive digital transformation in an FDA-regulated manufacturing industry (preferably medical device or pharmaceutical) supporting Supply Chain systems and designing GxP-compliant enterprise architecture including ERP, MES, QMS, LIMS and related integrations required.
  • A minimum five (5) years’ experience designing or supporting Data Lakes, Modeling, Warehousing and Governance preferred. 
  • First hand experience with SQL programming and performance tuning is required. 
  • Advanced programming knowledge in .NET Technologies, C#, VB.NET, Java, MS SQL Database programming and Oracle programming is required.
  • Experience implementing scalable and flexible 3rd party integrations with a comfort level using APIs.  
     

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.

Final compensation packages will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program. Rate of pay:  $100,00.00 - $150,000.00/year