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. ​​ ​ 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. ​ 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, clinical trials management, adverse event reporting, and medical information dissemination. Manage the demand and resourcing for their domain architecture team, understanding the architectural capability required to deliver solutions and manage resources. Inform business owners for their domain(s) with options to influence decisions. Support the Head of Enterprise Architecture to identify future capabilities the function will require to support the business. Establish and manage domain relationships with technology suppliers; developing ongoing relationships to maximize the value they deliver to Olympus, and ensuring Olympus is undertaking business on the best possible commercial terms. Work closely with other Lead EAs to define common architecture and solutions where applicable. Define and uphold the Enterprise Architecture guardrails for the Product Development & Regulatory Compliance domain. Ensure the delivery of high-level design and assuring the output adheres to the Enterprise Architecture guardrails. Coordinate and drive automation, new ways of working and tooling across delivery.

Job Qualifications Required:

Bachelor's degree or higher in Computer Science, Engineering (or equivalent and related experience preferred). Minimum 10 years' experience as an Enterprise Architect with touchpoints in R D, Quality Management, and regulatory compliance. Extensive experience with architectural frameworks such as TOGAF (The Open Group Architecture Framework), Zachman, etc. Experience in the Medical Technology industry, either in a MedTech company or in a Life Science Consulting company preferred. Extensive experience in software engineering and design architecture. Significant 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. Demonstrable knowledge of contributing to business aligned Technology strategies. Expert knowledge of technology integrations. Understanding of technology security and regulatory requirements. Understanding of technology trends. In-depth knowledge of working with business processes in the assigned domain, preferably in medical related fields. Demonstrable business and tech acumen. Demonstrable organizational skills. Why join Olympus? 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 Comprehensive medical, dental, vision coverage effective on start date 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 Paid Educational Assistance
• US Only
• Center Valley, PA and Westborough, MA Are you ready to be a part of our team?

Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks. The anticipated base pay range for this full-time position in this location is $144,541.00 - $216,812.00 / year, plus potential for annual bonus (subject to plan eligibility and other 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 OCAAccommodations@olympus.com. 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.

Posting Notes:

|| United States (US) || Pennsylvania (US-PA) || Center Valley || Information Technology (IT)