Director, Global Systems Engineering

Requisition ID:  34822  

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.

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%+

Target Pay Range:  $172,900.00 to $216,200.00  -  Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data

Target Bonus on Base:  30.0%

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.

• Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
• In 2024, Terumo Blood and Cell Technologies reached $1.5 billion in revenue.
• We employ nearly 8,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
• We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
• Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
  • Respect – Appreciative of others
  • Integrity – Guided by our mission
  • Care – Empathetic to patients
  • Quality – Committed to excellence
  • Creativity – Striving for innovation
• We contribute to the Leukemia and Lymphoma Society (LLS), raising $2.4 million USD since 2025.

We are proud to be an Equal Opportunity Affirmative Action Employer.  All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.

Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.