Software Devices and Digital Health Lead
The Lead, Software Devices and Digital Health Solutions, will a be a key contributor in the development and maintenance of software (SW) aspects related to Takeda?s PDT portfolio of medical devices and mobile applications. This role operates inside Takeda?s PDT business unit, which focuses on enabling delivery of digital device/health solutions that serve our patients? needs.
The role requires a blend of technical and commercial expertise, with the ability to understand business dynamics and customer needs, translate business needs into digital product concept roadmaps, decompose those roadmaps into specific software solutions. This role will interact and coordinate with cross-functional teams to generate concept design, develop solutions and scale the software solutions thru commercialization stage.
For example, this role will participate in the connectivity strategy focused on unlocking data from our products to power our pipeline of digital health products. Success in this area turns our devices into strategic and innovation assets as well as building appropriate technology ecosystem.
This role will also support creation of internal digital health platforms that accelerate development and delivery of our digital health pipeline, including areas like clinical decision support, digital diagnostics, or predictive analytics.
The organization is investing in its Digital Health focus and portfolio. An ideal candidate will be comfortable operating in a fast-paced environment, bring a unique lens of strategic and technical healthcare expertise to the table, and be an articulate and passionate internal change agent for Digital Health and digital transformation.
Essential Duties and Responsibilities
? This role sits at the intersection of business viability, technological feasibility, and customer needs
? The role will coordinate the execution of SW development projects, across the entire product lifecycle and have a strategic view of digital health solutions at Takeda
? Interact extensively with a wide variety of internal stake holders, most notably IT, Device Engineering, Human factors engineering, Quality, Regulatory Affairs and Global Product and Launch Strategy (GPLS).
? Work with external firm to manage the development activities and drive execution to meeting project milestones.
? Acquire and build a strong understanding of Takeda's product users and their unique needs around digital health
? Work collaboratively with business unit technical leaders to synchronize platform strategy and architecture, develop capabilities and components to facilitate adoption, implementation, and life cycle management.
? Influence device connectivity and interoperability strategy communicate and champion approach.
? Analyze multiple technical roadmaps to identify common elements and opportunities for collaboration, and reduce strategy to actionable steps delivering key digital product infrastructure
? Effectively communicate across multi-national/multi-site organization.
? Serve as technical SME in execution of enterprise clinical data and API strategy
? Support external partnerships to accelerate innovation, including EMRs or PaaS / SaaS solutions
? Serve as the ?thought partner? for the Plasma Derived Therapies business unit to support the patient/customer problem identification and identify potential digital technology solutions.
? Work effectively with cross functional teams including quality, marketing, IT, regulatory, and clinical to deliver high impact, on schedule, on budget technical solutions
? Global travel up to 25%
? Experience in developing SW based products in a regulated industry and a deep understanding of the SW development process.
? Prior experience in establishing or executing the organizational digital product strategy for connected products and SW applications.
? Technical leadership experience across a multi-business organization leading digital product development
? Working knowledge of Agile development in a regulated environment
? Highly proficient in current and emerging engineering methods, principles and system integration techniques related to real time embedded, cloud and enterprise software
? Ability to establish a technical vision, identify the tactical steps to achieve, foster innovation and lead a diverse global design team to realize the objective of the vision.
? Working knowledge of digital product regulation, quality, data privacy and residency
? Strong communication, collaboration, and influence skills; able to manage ambiguity and drive outcomes in complex organizational contexts
? Able to write clear and concise documentation, excellent written and spoken communication with superb presentation skills
? Experience with DevOps practices and CI/CD tools and processes
? Ideally, the candidate has familiarity working in the medical device or pharmaceutical industry and brings knowledge of industry best practices in design, development and regulation of medical devices, software-based medical devices, and mobile applications
? Prior experience in setting and driving the organizational digital health strategy for connected devices and SW applications for a medical device or pharmaceutical organization.
? Proven capability in the development of complex software based medical devices
? Experience developing software-based medical devices and/or mobile applications and platforms with a medical or healthcare focus
? Experience communicating with regulatory authorities during pre-subs, submissions, and related responses
? Built and shipped health IT applications incorporating: clinical decision support, predictive analytics, or machine learning / artificial intelligence
? Working knowledge of healthcare interoperability, HL7 v2, HL7 CDA, or FHIR protocols
? Experience with product & process development under QMS processes (ISO9001, ISO13485, CFR)
? Bachelor's degree in business, computer science, or related discipline; Master's degree preferred
? 10+ years engineering or development experience around digital product development in MedTech, health IT, life science, pharmaceutical or technology industry
? 5+ years of experience in establishing or executing an organizational digital product strategy for connected products and SW applications