Director, Global Systems Engineering

Terumo BCT, Inc. • Denver, CO

4d

About The Position

At Terumo Blood and Cell Technologies, our 8,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere.

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart.

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours.JOB SUMMARY
Reporting to the VP, Global Product Engineering, the Director of Global Systems Engineering is a highly impactful leadership role responsible for shaping the technical vision, strategy, and execution of Terumo Blood and Cell Technologies' global systems engineering organization. Leading a geographically diverse team across Lakewood, CO, India, and Costa Rica, this executive will co-author the multi-year technology roadmap and R&D strategy, drive the adoption of modern systems engineering practices - including Model-Based Systems Engineering (MBSE) and the Digital Thread - and foster a world-class "Systems Mindset" that ensures seamless integration across software, hardware, and human factors disciplines.

This leader acts as a critical bridge between commercial strategy and technical execution, partnering with Commercial teams to drive product differentiation, market share, and R&D return on investment. The role deploys top-tier technical talent - including Lead Systems Designers and Lead Systems Engineers (LSD/LSE) - to accelerate innovation and deliver life-saving medical device solutions to the market.

Requirements

• Bachelor of Science, engineering degree required
• Minimum 10 years developing medical devices, required
• Demonstrated experience managing geographically distributed engineering organizations across multiple cultures and time zones
• Deep expertise in medical device systems engineering with a proven track record from concept through commercial launch and full lifecycle management
• Strong command of Design Controls, Risk Management, and Quality Systems (cGMP, GDP, Six Sigma) with experience supporting FDA and international regulatory submissions
• Technical breadth spanning systems, software, hardware, human factors, and increasingly SaMD and cybersecurity, with the credibility to guide critical architectural trade-offs and design decisions
• Practical fluency in modern systems engineering tools and methods, including MBSE frameworks, requirements management platforms, and digital traceability solutions
• Strong customer advocacy grounded in understanding of clinical workflows, user environments, and unmet needs that drives meaningful product differentiation
• Proven ability to scale global operating models and build high-performing, cross-cultural teams, developing the next generation of Directors and technical fellows through coaching, sponsorship, and succession planning
• Effective change agent who drives adoption of improved engineering processes, tools, and best practices while maintaining team engagement, compliance standards, and organizational momentum through transformation
• Influences senior leadership, cross-functional partners, and global teams with credibility, clarity, and the ability to translate complex technical concepts into business-relevant narratives
• Track record of delivering complex medical device programs on time and on budget with strong quality metrics, balancing engineering rigor with commercial reality to optimize portfolio outcomes and drive ROI

Nice To Haves

• Master of Science and/or Business degree preferred
• Minimum 8 years of systems design, medical device and/or leading engineering teams, preferred
• Experience with Model-Based Systems Engineering (MBSE), Digital Thread, or Digital Twin initiatives strongly preferred
• Background in complex connected medical devices, Software as a Medical Device (SaMD), or data-driven device architectures preferred

Responsibilities

• Co-author the multi-year technology roadmap and R&D strategy in partnership with the VP, Global Product Engineering, ensuring alignment with business objectives and market opportunities
• Champion the adoption and maturation of modern systems engineering frameworks - including MBSE, the Digital Thread, and Digital Twins - to accelerate development velocity and improve cross-domain traceability
• Drive the integration of a "Systems Mindset" across the global engineering organization, ensuring usability, serviceability, reliability, and manufacturability are embedded from concept through commercialization
• Establish architectural standards and governance for increasingly connected, data-driven medical devices, including Software as a Medical Device (SaMD) and cybersecurity considerations
• Lead the design control process with accountability for user needs, product requirements, verification/validation, risk management, and cross-domain traceability across systems, software, human factors, and software quality engineering
• Oversee the deployment and effectiveness of Lead Systems Designers and Lead Systems Engineers (LSD/LSE) embedded within programs, ensuring disciplined execution and sound technical decision-making at the program level
• Evaluate proposed solutions, adaptations, and modifications to products and systems, applying technical breadth and engineering judgment to drive decisions with cross-functional impact
• Assess, manage, and mitigate technical and execution risks across the product portfolio, providing transparent status and escalation to senior leadership
• Build and scale a seamless, globally distributed systems engineering center of excellence across Lakewood, India, and Costa Rica - driving cross-cultural R&D integration, consistent operating models, and world-class delivery standards
• Develop the next generation of engineering leaders, including Directors and high-level technical fellows, through structured mentorship, stretch assignments, and deliberate succession planning
• Partner with Commercial teams to translate customer, clinical, and market needs into differentiated product strategies that drive revenue growth, market share, and R&D return on investment
• Ensure compliance with FDA, CE, and other global regulatory requirements in partnership with Regulatory, Quality, and cross-functional colleagues

Benefits

• At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.

What This Job Offers

• Job Type: Full-time
• Career Level: Director