Hiring: VP Global Software Development Company: Terumo Blood and Cell Technologies Location: Lakewood, CO Job Posted Time: 2026-09-10 11:16:28 Employment Type: On-site Target Skills & Keywords : Embedded Systems, MLOps, Product Management, Project Management, R, Regulatory Compliance, Risk Management, SBOM, Systems Engineering About the job Required Skills: •Sets and owns the global software engineering vision and multi-year strategy, ensures it is integrated into Terumo BCT’s corporate strategy, and translates 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. •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. Qualifications: •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. •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. •Hands-on experience adopting modern AI software engineering tooling (for example, AI-assisted coding, code review, and test generation) with the validation, traceability, and data/IP protection a regulated environment requires. Compensation: •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!