Senior Director, Digital Products

Senior Director, Digital Products & Innovation Se pueden requerir diversas habilidades interpersonales y experiencia para el siguiente puesto. Por favor, asegúrese de consultar la descripción a continuación con atención. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Overview The Senior Director of Digital Products & Innovation will — in partnership with our specialized business units — lead the strategy development of our customer-facing, transversal digital products and support the commercialization of next-generation digital products that transform the clinical diagnostics experience — spanning instrument connectivity, workflow automation, laboratory informatics, analytics, and remote services. This role is explicitly focused on in vitro diagnostics and designing and launching software-enabled solutions that integrate with analyzers, LIS/EHR systems, and enterprise platforms to elevate lab efficiency, clinical decision‐making, and operational value. This role bridges market needs and development capabilities, ensuring digital products meet customer demands and business goals. Responsibilities Digital Product Strategy Own, in partnership with our specialized business units, the multi‐year digital roadmap across instrument connectivity, workflow orchestration, middleware, and analytics. Own and drive the digital strategy to support specialization, understanding trends, opportunities and translating them into requirements for our digital solutions. Drive portfolio planning, product lifecycle management, and value realization for digital products in partnership with the business units. Innovation & Emerging Technology Foster accelerated innovation via rapid ideation, prototyping, and clinical validation of concepts, decision support, predictive maintenance, and remote diagnostics, leveraging our Digital Factory and Clinical Software teams. Evaluate and integrate enabling technologies to power connected diagnostics and smart labs. Mature internal digital innovation and create partnerships with startups, academic centers, and technology vendors. Operational Excellence & Commercial Impact Design digital offerings that deliver measurable improvements in lab throughput, turnaround time, uptime, and total cost of ownership. Establish robust telemetry, performance analytics, and voice‐of‐customer feedback loops for continuous improvement. SaaS, subscription, outcome‐based models) and partner with commercial and customer service‐ and success teams. Integrate solutions into existing Quality Management Systems ensuring IVD best practices across design and development. Partner with Clinical, Regulatory, and Quality to ensure alignment to design controls, risk management (ISO 14971), and software lifecycle (IEC 62304), as well as ensuring compliance with IVD and SaMD requirements (e.g., FDA, IVDR, ISO 13485) and data privacy/security obligations. Lead go‐to‐market readiness for IVD digital solutions, partnering with Quality and Regulatory to include labeling, UDI/traceability, cybersecurity documentation, and post‐market surveillance processes. Mentor and grow a cross‐functional team of product managers, and other roles in support of the digital strategy. Foster tight collaboration with instrument R&D, service, IT/Cloud, and commercial teams to align digital initiatives with core diagnostic product lines and growth strategies. Co‐create packaged solutions that combine BU specialization with the digital platform (connectivity, data, analytics, remote service) to deliver measurable outcomes. Identify regulatory and cybersecurity strategies that could be harmonized across BUs using shared processes and artifacts. The Senior Director owns cross‐BU workflow design, the shared digital platform, and related enterprise‐scale capabilities, ensuring alignment with Werfen's digital strategy. Senior Director (Own): cross‐BU workflow orchestration, shared data & analytics and, in collaboration with R&D teams, identify common platform capabilities, interoperability standards/APIs, identity/security/privacy controls, DevOps/SRE, and design system. In collaboration with R&D, Cybersecurity, QA and RA: Workflow orchestration across analyzers, middleware, LIS/EHR, and cloud services. Device onboarding/provisioning, remote service & telemetry, predictive maintenance models. Common data platform: streaming pipelines, lakehouse/warehouse, semantic models (e.g., LOINC mapping), data governance/MDM. Unified UX: component library/design system for consistent clinician and lab experiences. Security & privacy by design: identity/access (RBAC), consent, audit, SBOMs, vulnerability and patch management, secure software updates (OTA). Cloud/edge operations: observability, SLOs/SLAs, incident management, continuous delivery, automated testing and validation. Regulatory enablement: shared IEC 62304/ISO 14971/ISO 13485 artifacts, cybersecurity documentation, labeling/UDI support, In collaboration with commercial teams: ~ Commercial enablement: packaging and pricing for platform + BU offerings (SaaS/subscription/outcome‐based), telemetry for value realization Alignment with Werfen Digital Strategy Adopt enterprise principles: interoperability‐first, security‐ and privacy‐by‐design, cloud‐first/edge‐aware, data ethics and compliance. instrument uptime, TAT improvement, workflow automation rates, platform adoption). Lead Digital Architecture Council with BU product‐and engineering leaders to govern standards, APIs, and shared services. Bachelor's degree in engineering, Computer Science, Biomedical Engineering, or related field (Master's or MBA preferred). ~12–15 years in digital product management/innovation for medical devices or healthcare tech, with at least 7–10 years specifically in IVD. ~ Proven track record launching regulated, commercial IVD digital products (middleware, connectivity, remote diagnostics/service, analytics) at scale. ~ Experience across the full IVD lifecycle: design controls, verification/validation in clinical settings, submission support, and post‐market surveillance. Strategic thinker balancing technical depth with commercial and operational acumen. Expertise in agile product development, user‐centered design, and innovation frameworks (Design Thinking, Lean Startup). Exceptional communication and stakeholder management across R&D, regulatory/quality, services, and commercial leadership. Passion for transforming diagnostics through data, automation, and interoperable digital ecosystems.