Enterprise Architect (Product Development & Regulatory Compliance)

Olympus America, Inc.; Pennsylvania; Hybrid; USD 135.000 - 189.000; Vollzeit

Benefits dieser Stelle

Competitive salaries and annual bonus

401(k) with company match

24/7 Employee Assistance Program

Wellbeing programs (live/on-demand)

Generous paid vacation and sick time

Parental leave and adoption assistance

Paid holidays

On-site daycare, café, fitness center

Zusammenfassung

Olympus America, Inc. is seeking an Enterprise Architect to shape and govern the domain architecture for Product Development, Regulatory & Compliance, enabling faster, safer, and AI-enabled product innovation while ensuring sustained regulatory compliance.

The role collaborates across QA, QMS, RIM, and ERP systems to deliver audit-ready digital platforms. The ideal candidate will define target-state capabilities, reference architectures, and roadmaps, and ensure build/buy decisions align with

Qualifikationen

• Bachelor’s degree or higher in Computer Science, Engineering (or equivalent and related experience).
• Extensive experience with architectural frameworks such as TOGAF (The Open Group Architecture Framework), Zachman, etc.
• Broad experience in software engineering and design architecture (certification preferred).
• Experience in defining architecture policies and frameworks.
• Advanced understanding of business analysis techniques and processes.
• Knowledge and experience in project management, process modelling, data modelling and systems analysis.
• Cloud, SaaS, AI & Automation Governance—Govern adoption of cloud and SaaS platforms for regulated workloads, including configuration control, validation, and operational resilience.
• Define architecture for AI-enabled and automated systems, ensuring transparency, explainability, and regulatory alignment.
• Promote automation across the lifecycle (validation, testing, reporting, compliance monitoring).
• Evaluate emerging technologies and define safe adoption patterns in regulated environments.

Aufgaben

• Co-create the domain target architecture and multi-year roadmap with business and IT leadership for Product Development and Regulatory & Compliance (QARA), aligned to enterprise strategy, value streams, and measurable outcomes.
• Drive product lifecycle “digital thread” thinking and define the enabling capability map and reference architectures.
• Continuously scan MedTech/Life Sciences trends and translate opportunities into actionable architecture options and investment recommendations.
• Provide architecture input to business cases and portfolio planning, including total cost of ownership, risk posture, validation/assurance effort, and change impact.
• Contribute to an innovation agenda for the domain, prioritizing scalable platforms and reusable capabilities over point solutions while respecting regulatory and quality constraints.
• Architect and evolve the domain landscape across R&D/PLM, Quality Management Systems, Regulatory Information Management, document/records management, training, audit, and supplier quality—ensuring coherent end-to-end processes and data flows.
• Translate business capabilities and requirements into architecture decisions (build/buy, SaaS/platform fit, integration patterns, data ownership), balancing speed, compliance, and operational resilience.
• Define and maintain domain reference architectures, standards, and reusable patterns (API-first integration, event-driven patterns where appropriate, master/reference data patterns, and document-centric workflows).
• Ensure solutions meet regulated requirements and quality expectations (e.g., GxP, 21 CFR Part 11/Annex 11, ISO 13485, ISO 14971), including auditability, traceability, and electronic records/signatures.
• Embed Computer System Validation and Computer Software Assurance principles into solution design, delivery ways-of-working, and vendor management, in partnership with Quality and validation teams.
• Partner with cybersecurity, privacy, and data governance to ensure security-by-design, compliant data handling, and appropriate controls across cloud and on-prem environments.
• Guide solution teams through architecture reviews and key design decisions, resolving cross-domain dependencies and enabling interoperability with ERP, manufacturing, clinical, and customer/post-market systems as required.
• Define, socialize, and uphold domain architecture guardrails and standards aligned to enterprise policies and regulated context.
• Run or support architecture governance for the domain and ensure traceability from business need to design decisions.
• Promote modern engineering and operating practices while maintaining compliance, validated state, and audit readiness.

Kenntnisse

TOGAF

Zachman

Architecture design

Cloud governance

AI & automation governance

Regulatory compliance awareness

Ausbildung

Bachelor’s degree in Computer Science or Engineering

Tools

Cloud platforms (AWS/Azure)

ERP integrations

Data modelling tools

Jobbeschreibung

Enterprise Architect (Product Development & Regulatory Compliance)

Working Location:Massachusetts, Westborough; Pennsylvania, Center Valley

Workplace Flexibility:Hybrid

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

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

Our five Core Values empower us to achieve Our Purpose:

Patient Focus, Integrity, Innovation, Impact and Empathy.

The Enterprise Architect (Product Development, Regulatory & Compliance) shapes and governs the domain architecture that enables faster, safer, and AI-enabled product innovation while ensuring sustained regulatory compliance.

The role defines target-state capabilities, reference architectures, and multi-year transformation roadmaps across the end-to-end product lifecycle—from idea-to-market through post-market surveillance. It ensures solutions are compliant-by-design, secure-by-design, and increasingly intelligent through AI and automation, while aligned to Olympus’ business strategy and regulatory obligations.

Working across Enterprise Architecture, Solution Architecture, Product, Quality, Regulatory, and Engineering teams, this role enables scalable, resilient, and audit-ready digital platforms that support continuous innovation in a highly regulated environment.

“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

• Co-create the domain target architecture and multi-year roadmap with business and IT leadership for Product Development and Regulatory & Compliance (QARA), aligned to enterprise strategy, value streams, and measurable outcomes.
• Drive product lifecycle “digital thread” thinking (requirements, design controls, risk, verification/validation, change control, submissions, post-market) and define the enabling capability map and reference architectures.
• Continuously scan MedTech/Life Sciences trends (cloud/SaaS, data platforms, AI, automation, digital quality, interoperability standards) and translate opportunities into actionable architecture options and investment recommendations.
• Provide architecture input to business cases and portfolio planning, including total cost of ownership, risk posture, validation/assurance effort, and change impact.
• Contribute to an innovation agenda for the domain, prioritizing scalable platforms and reusable capabilities over point solutions while respecting regulatory and quality constraints.
• Architect and evolve the domain landscape across R&D/PLM, Quality Management Systems (QMS/eQMS), Regulatory Information Management (RIM), document/records management, training, audit, and supplier quality—ensuring coherent end-to-end processes and data flows.
• Translate business capabilities and requirements into architecture decisions (build/buy, SaaS/platform fit, integration patterns, data ownership), balancing speed, compliance, and operational resilience.
• Define and maintain domain reference architectures, standards, and reusable patterns (API-first integration, event-driven patterns where appropriate, master/reference data patterns, and document-centric workflows).
• Ensure solutions meet regulated requirements and quality expectations (e.g., GxP, 21 CFR Part 11/Annex 11, ISO 13485, ISO 14971), including auditability, traceability, and electronic records/signatures.
• Embed Computer System Validation (CSV) / Computer Software Assurance (CSA) principles into solution design, delivery ways-of-working, and vendor management, in partnership with Quality and validation teams.
• Partner with cybersecurity, privacy, and data governance to ensure security-by-design, compliant data handling, and appropriate controls across cloud and on-prem environments.
• Guide solution teams through architecture reviews and key design decisions, resolving cross-domain dependencies and enabling interoperability with ERP, manufacturing, clinical, and customer/post-market systems as required.
• Define, socialize, and uphold domain architecture guardrails and standards (application, integration, data, identity/access, logging/audit, validation, and vendor/SaaS controls), aligned to enterprise policies and the regulated context.
• Run or support architecture governance for the domain (decision records, reference architectures, technology standards, and exception handling) and ensure traceability from business need to design decisions.
• Promote modern engineering and operating practices (product-centric delivery, platform thinking, automation, observability, and resilience) while maintaining compliance, validated state, and audit readiness.

Job Qualifications

Required:

• Bachelor’s degree or higher in Computer Science, Engineering (or equivalent and related experience).
• Extensive experience with architectural frameworks such as TOGAF (The Open Group Architecture Framework), Zachman, etc.
• Broad experience in software engineering and design architecture (certification preferred).
• Experience in defining architecture policies and frameworks.
• Advanced understanding of business analysis techniques and processes.
• Knowledge and experience in project management, process modelling, data modelling and systems analysis.
• Cloud, SaaS, AI & Automation Governance Govern adoption of cloud and SaaS platforms for regulated workloads, including configuration control, validation, and operational resilience
• Define architecture for AI-enabled and automated systems, ensuring transparency, explainability, and regulatory alignment
• Promote automation across the lifecycle (validation, testing, reporting, compliance monitoring)
• Evaluate emerging technologies and define safe adoption patterns in regulated environments
• Demonstrable knowledge of contributing to business aligned Technology strategies.
• Knowledge of technology integrations.
• Understanding of technology security and regulatory requirements.
• Understanding of technology trends.
• Demonstrable business and tech acumen.
• Detail orientated.

Preferred:

• Minimum 7 years' experience as an Enterprise Architect with touchpoints in R&D, Quality Management, and regulatory compliance preferred.
• Experience in the Medical Technology industry, either in a MedTech company or in a Life Science Consulting company preferred.

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Equitable Offerings you can count on:

Competitive salaries, annual bonus and 401(k)* with company match

24/7 Employee Assistance Program

Free live and on-demand Wellbeing Programs

Generous Paid Vacation and Sick Time

Paid Parental Leave and Adoption Assistance*

12 Paid Holidays

On-Site Child Daycare, Café, Fitness Center**

Connected Culture you can embrace:

Work-life integrated culture that supports an employee centric mindset

Offers onsite, hybrid and field work environments

Paid volunteering and charitable donation/match programs

Employee Resource Groups

Dedicated Training Resources and Learning & Development Programs

The anticipated base pay range for this full-time position in this location is$134,666.00-$188,532.00/ year, plus potential for annual bonus(subject toplan eligibility andother requirements).

Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.

At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com .

You Belong at Olympus

We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.

Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact [e-mail]. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Let’s realize your potential, together.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.