Enterprise Architect Lead (Product Development & Regulatory Compliance)

Working Location: Massachusetts, Westborough; California, San Jose; Minnesota, Brooklyn Park; Tennessee, Bartlett 

Workplace Flexibility: Hybrid

 

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​​

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Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

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Our five Core Values empower us to achieve Our Purpose: 

Patient Focus, Integrity, Innovation, Impact and Empathy. 

 

Learn more about Life at Olympus: https://www.olympusamerica.com/careers.

Job Description

 

The Lead Enterprise Architect (Product Development & Regulatory Compliance) is responsible for developing a forward-looking technology strategy and roadmap for their assigned domain, which translates business vision and objectives into technology initiatives and investments which then can be collaboratively refined together with senior business and IT stakeholders to ensure that business and IT needs are fulfilled. To achieve this the Lead EA collaborates across EA domains and Global IT functions to contribute to the overall EA and Global IT mission. The Lead EA manages architecture resource to design and evolve the strategy and roadmap within their domain and deliver the architecture principles to support design and implementation.

 

“The job is conducted in line with our Core Values which are: Patient Focus, Integrity, Innovation, Impact and Empathy. Olympus is an equal opportunities employer championing a culture of equality, diversity and inclusion embedded throughout the organization and workforce.”

Job Duties

• Define a compelling architectural vision for the Product Development & Regulatory Compliance domain, which includes the following Olympus business functions: i) Research & Development, ii) Regulatory Affairs, iii) Quality Management and iv) Medical & Scientific Affairs.
• Support the creation of business strategies providing technology expertise and an understanding of MedTech industry technology trends and best practice to inform business.
• Develop a clear business-led technology strategy and roadmap for the Product Development & Regulatory Compliance domain, ensuring alignment to the overall Global IT technology strategy and roadmap.
• Supports the Head of Enterprise Architecture in making strategic choices about the specific technologies Olympus will use (e.g., build vs buy etc.).
• Ensure alignment between the Product Development & Regulatory Compliance domain technology roadmap and the current and future priorities of Olympus.
• Monitor emerging technologies and assess their suitability for Olympus.
• Inputs into an up-to-date, forward-thinking innovation agenda for Olympus, specific to the Product Development & Regulatory Compliance domain.
• Provide Enterprise Architecture inputs and advice for Business Case development (technology, people, and processes).
• Provide Architecture Subject Matter Expert (SME) oversight for the Product Development & Regulatory Compliance domain.
• Create and develop a domain reference architecture for the Product Development & Regulatory Compliance domain, influencing the overarching Olympus reference architecture.
• Collaborate with R&D team(s) to understand technology needs for experimental design, data analysis, and simulation and develop IT strategies that support accelerated product development based on their needs. Evaluate emerging technologies such as artificial intelligence and machine learning for predictive modeling and data analytics in R&D.
• Collaborate with Regulatory Affairs team(s) to align the IT architecture to facilitate regulatory submissions, document management, and compliance tracking and to ensure adherence to global regulatory standards.
• Collaborate with Quality Management team(s) to define IT strategies to enhance quality control processes, including automation of testing, validation, and release management.
• Ensure IT systems supporting quality assurance and quality control processes adhere to industry-specific regulatory requirements.
• Collaborate with Medical & Scientific Affairs team(s) to define IT architecture for medical evidence generation, c