VP Global Software Development

VP Global Software Development

Terumo BCT helps unlock the potential of blood and cells to treat serious disease. Our platforms collect and process blood components, perform therapeutic apheresis for conditions such as sickle cell disease, and enable cell and gene therapies, including CAR-T, for customers in more than 150 countries. Increasingly, software is what advances these platforms: the embedded intelligence in our devices, the connected applications and data around them, and the AI/ML capabilities that will shape the next generation of care. The Vice President of Global Software Engineering leads the global organization at the center of that shift. Reporting to the Senior Vice President, Research and Development, this leader owns the software engineering and technology strategy and builds the teams and platforms to deliver it. The portfolio is broad: embedded device software, connected applications and services, cloud and data platforms, and AI/ML-enabled clinical solutions. Working with partners across the company, this leader turns clinical, customer, and market insight into software that is high in quality, safe, and commercially successful, with accountability for product quality, cybersecurity, and regulatory compliance across the full product lifecycle. A central part of the role is bringing modern, AI-assisted software engineering into a regulated environment: using today's tooling to raise quality and speed while preserving the human judgment, validation, and traceability that medical software demands. This leader also builds lasting relationships with key opinion leaders, regulators, and technology partners so that Terumo BCT stays current as software, AI, and cybersecurity keep evolving. This leader directs a global organization of roughly 160 teammates with an annual budget of over $25M, spanning the full software discipline: software engineering, software quality engineering, software development in test, DevOps, data and analytics, software project management, and product cybersecurity. Because Terumo BCT builds integrated hardware and software medical devices that require rigorous V-model documentation, Software Systems Engineering sits within the Systems Engineering function, and this leader partners closely with that group across the V-model. The role also works closely with the Software Product Technology Lead in R&D, who owns holistic, full-lifecycle planning for application-software product lines with Marketing and the commercial organization, to align engineering delivery with product-line and go-to-market plans. The team works globally through centers of excellence, each responsible for specific product lines and lifecycle phases. Most of the group is based in Lakewood, Colorado, with additional centers in India and Costa Rica and two key outsourcing partners; this leader runs this blended in-source and out-source model, including partner selection, governance, and performance. This is an onsite role based in Lakewood, Colorado, with a minimum of three days per week in the office.

Essential duties include setting and owning the global software engineering vision and multi-year strategy, ensuring it is integrated into Terumo BCT's corporate strategy, and translating it into an executable roadmap with clear milestones, dependencies, and measurable business outcomes. Leads execution of the software roadmap; anticipates and pre-empts risks to scope, schedule, quality, and budget across the full software portfolio. Builds and leads a strong global engineering organization talent strategy, leadership development, succession, and workforce planning and a culture of accountability, learning, and inclusion. Embeds quality and regulatory rigor across the software development lifecycle, including Design Controls, Product Development Governance, and risk management, ensuring compliance with all applicable global medical device software, quality, risk management, and human factors regulations. Owns product cybersecurity end to end, including secure-by-design architecture, threat modeling, SBOM and software supply chain integrity, vulnerability management, secure SDLC, and post-market monitoring, aligned to IEC 81001-5-1, FDA premarket cybersecurity guidance, and applicable global requirements. Leads strategy and governance for AI/ML in two areas. First, AI/ML inside Terumo BCT products: model lifecycle and validation, Predetermined Change Control Plans (PCCPs), data governance, bias and performance monitoring, FDA AI-enabled Device Software Functions guidance, and EU AI Act obligations. Second, the use of modern AI software engineering tooling by the team itself, such as AI-assisted coding, code review, test generation, and documentation, with the validation, traceability, IP protection, and human oversight that a regulated environment requires. Drives platform thinking and reusable software architecture across product lines, including common services, APIs, interoperability (HL7, FHIR, IHE), DevSecOps, cloud/edge/embedded patterns, and a scalable data and analytics platform that turns device and clinical data into useful insight and commercial value. The goal is to bring products to market faster while keeping total cost of ownership down. Establishes modern engineering performance management using DORA and SPACE metrics, defect and field-quality KPIs, and compliance and cybersecurity indicators, tied directly to business and patient-safety outcomes. Partners with Product Management, Regulatory Affairs, Clinical Affairs, Quality, Manufacturing, and Commercial to translate clinical and customer needs into shippable software and to develop integrated regulatory, clinical, and technical documentation strategies. Leads adoption of customer- and clinician-centered design practices, including human factors engineering, contextual research, and voice-of-customer feedback, so that software-driven products and services are safe, effective, and easy to use. Manages the global software engineering portfolio: operating and capital budgets, capacity, vendor and partner ecosystem, and the balance of in-sourced versus out-sourced delivery, with rigorous prioritization and ROI discipline. Tracks the external environment, including competitive, technology, AI/ML, cybersecurity, regulatory, and standards developments, and translates it into strategic bets, proofs of concept, and well-judged investment decisions.

Minimum qualification requirements include a Master's degree in Engineering or Computer Science, or a Bachelor's degree with equivalent education and experience sufficient to successfully perform the essential functions of the job. Required qualifications include minimum 15 years of progressive software development and engineering experience commercializing complex regulated products embedded device software, connected applications, cloud/data platforms, and AI/ML-enabled solutions in a highly matrixed, global healthcare environment, including 710 years of engineering leadership and significant experience leading global, distributed teams. Proven success bringing software-driven medical products through the full lifecycle (proof of concept through commercialization and post-market) using modern, efficient software practices, including DevSecOps and platform-based delivery. Deep working knowledge of medical device software regulation and quality systems: IEC 62304, ISO 13485, ISO 14971, IEC 62366, 21 CFR Part 820, EU MDR, and the FDA AI/ML SaMD and cybersecurity framework, with direct experience leading audits and submissions. Demonstrated leadership of product cybersecurity programs and secure SDLC, including SBOM, vulnerability management, and IEC 81001-5-1 alignment. Demonstrated leadership of AI/ML in regulated products, including model lifecycle and validation, and the governance and human oversight a regulated environment requires. Proven ability to manage complex global budgets, capital plans, and in-sourced/out-sourced delivery portfolios, and to lead large-scale organizational change with measurable improvement in delivery speed, quality, and engagement. Demonstrated success leading geographically distributed engineering teams and a blended in-source/out-source model across multiple regions and time zones, including selection, onboarding, and performance management of strategic partners. Executive presence and the ability to align and persuade senior stakeholders across a complex, matrixed, global organization, and to represent the software engineering and technology strategy with the executive team, regulators, key opinion leaders, and technology partners. A genuine commitment to people: building inclusive, high-performing engineering cultures and developing leaders through workforce planning, leveling, succession, and manager development at scale.