Senior Director, Strategic Platform Execution

Sr Director Strategic Platform Execution The Senior Director, Strategic Platform Execution leads a global organization accountable for bringing TerumoBCT's devices, disposables, and software to market. It owns how that work is planned, prioritized, sequenced, and delivered across multiple sites, along with the standards and governance that keep delivery predictable, and it is the senior R&D voice on what TerumoBCT builds and in what order. The Senior Director advises executive leadership on long-range strategy and investment, settles competing priorities, and is accountable for the results that follow, from growth in market share to lower cost and stronger product quality in developed and emerging markets. The same is true of Commercial, including Enterprise Marketing, where this organization is R&D's chief partner. Together they shape roadmaps, product line strategies, and value propositions, and they run Product Lifecycle Management as a shared process across functions. The Senior Director is accountable for turning what Commercial needs into commitments R&D can meet. Strategic Platform Execution is newly formed, and whoever takes it on will help decide how it is built and how TerumoBCT develops products in the years ahead. Is the senior authority and "go to" global leader for platform, program, and project execution across the devices, disposables, and software portfolio, and represents the organization on significant matters with internal and external stakeholders Owns planning and decision-making for the portfolio, and advises top management on long-range direction for the global platform strategy Is the primary R&D interface to the Commercial organization, including Enterprise Marketing. Partners with them on roadmapping, product line strategies, value propositions, and cross-functional Product Lifecycle Management, and brings forward new product opportunities with a clear view of value and risk Designs and implements frameworks for R&D operational excellence, including standard methods for project execution, resource use, performance measurement, and continuous improvement Sets the criteria that decide when work is insourced, outsourced, or done with a partner, and leads partner selection, integration, and ongoing governance Establishes systematic approaches for portfolio management, resource planning, and program execution, working with the engineering functions across multiple global sites Defines metrics and governance that track operational performance and progress on change, and that reward the way the organization wants to work Determines the structure and staffing this organization requires, and is responsible for reviewing, evaluating, and developing its leaders and teams while working across a global, cross-functional environment Works across regional and functional boundaries to meet business objectives and project timelines Ensures product design and documentation meet FDA and global regulatory requirements, sets standards for technical documentation and product lifecycle management, and leads or sponsors quality system remediation and major quality initiatives Communicates with senior management and external customers on program, strategic, and business matters, and explains complex solutions to both technical and non-technical audiences S. or PhD degree in Engineering combined with management degree preferred Minimum of 5 years medical device industry or equivalently regulated industry Commercialized products delivered that combine devices, disposables, and software, and the candidate's specific accountability for each Delivery through insourced, outsourced, and partnered development models, including the partners selected, the structures used, and the outcomes achieved Direct engagement with FDA or comparable regulatory bodies, including submissions, inspections, or audits, and the candidate's role in each Credible as both a platform authority and an operational leader, setting portfolio direction while owning the discipline that delivers it Deep command of Design Controls and Quality Management Systems, with the standing to lead quality system remediation and defend decisions to regulators Fluent in portfolio and program management methods, and able to apply them at global, multi-site scale Builds and matures build, buy, and borrow capability, setting up sourcing and partnership models and strengthening them over time Structures and governs external development relationships that hold quality, design control, intellectual property, and schedule accountability without giving up internal ownership Sound judgment on platform trade-offs, and able to guide top management on portfolio direction, sequencing, and investment Connects platform roadmaps to business results such as market share, cost, margin, and time to market Uses performance data to find and close execution gaps rather than to report status Makes trade-off decisions on scope, resources, quality, and risk with incomplete information -Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Up to 25% international travel required