Global Director of Systems Engineering
Terumo Blood and Cell Technologies, Denver, CO, United States
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.
ESSENTIAL DUTIES
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 MINIMUM QUALIFICATION REQUIREMENTS
Education
Bachelor of Science, engineering degree required Master of Science and/or Business degree preferred Experience
Minimum 10 years developing medical devices, required Minimum 8 years of systems design, medical device and/or leading engineering teams, preferred Demonstrated experience managing geographically distributed engineering organizations across multiple cultures and time zones 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 Skills
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 LEADERSHIP PROFILE / EXPECTATIONS & COMPETENCIES
Strategic Mindset / Global Perspective- thinks strategically and broadly with varied viewpoints to effectively implement plans.Thinks critically and is a creative problem solver for the short and long-term challenges. Business Acumen / Customer Focus – understands the market, industry trends, the complex ecosystem of the business area, and anticipates and uses customer insights that provide products and services beyond customer expectations with the committed financial result (revenue, margin). Influencing / Business Partnering – can flex styles and builds relationships to partner across internal/external by leading through influence. “Makes Things Happen . . Together” - Drives for Results / Ensures Accountability – sets aggressive goals, translates strategy into execution, promote a sense of urgency, and persists in the face of challenges and setbacks. “Brings Out The Best in Others” - Drives Engagement (Influencing across functions/regions) – builds relationships across regions, creates a positive and motivating global work environment where contributions are visible and valued Builds Teams and Develops Talent – develops and enables diverse high-performing cross-functional teams in highly matrixed environments. Has a passion and ability to coach, mentor, and motivate individuals and teams. Instills Trust
- unquestionable integrity, ethics, and character. A role model for the Terumo Core Values. “Champions a Growth Mindset” – values progress, experiments and learns from others Culture/Motivational Fit
– can thrive and work in a VUCA environment (volatility, uncertainty, complexity, ambiguity), and willing to travel with flexible work hours driven by global time zones. PHYSICAL REQUIREMENTS
Typical Office Environment requirements include: reading, speaking, hearing, close vision,bending, sitting, and occasional lifting up to 20 lbs. The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties Additional Physical Requirements
Domestic and international travel, 10-15%+
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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 MINIMUM QUALIFICATION REQUIREMENTS
Education
Bachelor of Science, engineering degree required Master of Science and/or Business degree preferred Experience
Minimum 10 years developing medical devices, required Minimum 8 years of systems design, medical device and/or leading engineering teams, preferred Demonstrated experience managing geographically distributed engineering organizations across multiple cultures and time zones 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 Skills
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 LEADERSHIP PROFILE / EXPECTATIONS & COMPETENCIES
Strategic Mindset / Global Perspective- thinks strategically and broadly with varied viewpoints to effectively implement plans.Thinks critically and is a creative problem solver for the short and long-term challenges. Business Acumen / Customer Focus – understands the market, industry trends, the complex ecosystem of the business area, and anticipates and uses customer insights that provide products and services beyond customer expectations with the committed financial result (revenue, margin). Influencing / Business Partnering – can flex styles and builds relationships to partner across internal/external by leading through influence. “Makes Things Happen . . Together” - Drives for Results / Ensures Accountability – sets aggressive goals, translates strategy into execution, promote a sense of urgency, and persists in the face of challenges and setbacks. “Brings Out The Best in Others” - Drives Engagement (Influencing across functions/regions) – builds relationships across regions, creates a positive and motivating global work environment where contributions are visible and valued Builds Teams and Develops Talent – develops and enables diverse high-performing cross-functional teams in highly matrixed environments. Has a passion and ability to coach, mentor, and motivate individuals and teams. Instills Trust
- unquestionable integrity, ethics, and character. A role model for the Terumo Core Values. “Champions a Growth Mindset” – values progress, experiments and learns from others Culture/Motivational Fit
– can thrive and work in a VUCA environment (volatility, uncertainty, complexity, ambiguity), and willing to travel with flexible work hours driven by global time zones. PHYSICAL REQUIREMENTS
Typical Office Environment requirements include: reading, speaking, hearing, close vision,bending, sitting, and occasional lifting up to 20 lbs. The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties Additional Physical Requirements
Domestic and international travel, 10-15%+
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