Ph3Senior Director, Digital Products Innovation /h3 pWerfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. /p h3Overview /h3 pThe 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. /p h3Responsibilities /h3 pbDigital Product Strategy /b /p ul liOwn, in partnership with our specialized business units, the multi‑year digital roadmap across instrument connectivity, workflow orchestration, middleware, and analytics. /li liOwn and drive the digital strategy to support specialization, understanding trends, opportunities and translating them into requirements for our digital solutions. /li liTranslate clinical functionality and operational needs, defined with the business units, into scalable and harmonized platforms and solutions. /li liDrive portfolio planning, product lifecycle management, and value realization for digital products in partnership with the business units. /li /ul pbInnovation Emerging Technology /b /p ul liFoster 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. /li liEvaluate and integrate enabling technologies to power connected diagnostics and smart labs. /li liMature internal digital innovation and create partnerships with startups, academic centers, and technology vendors. /li /ul pbOperational Excellence Commercial Impact /b /p ul liDesign digital offerings that deliver measurable improvements in lab throughput, turnaround time, uptime, and total cost of ownership. /li liEstablish robust telemetry, performance analytics, and voice‑of‑customer feedback loops for continuous improvement. /li liOwn adoption and monetization strategies (e.g., SaaS, subscription, outcome‑based models) and partner with commercial and customer service‑ and success teams. /li /ul pbIVD Domain Leadership Compliance /b /p ul liIntegrate solutions into existing Quality Management Systems ensuring IVD best practices across design and development. /li liPartner 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. /li liLead 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. /li /ul pbLeadership Collaboration /b /p ul liMentor and grow a cross‑functional team of product managers, and other roles in support of the digital strategy. /li liFoster tight collaboration with instrument RD, service, IT/Cloud, and commercial teams to align digital initiatives with core diagnostic product lines and growth strategies. /li liCommunicate strategy, progress, and outcomes to the executive team and broader organization. /li /ul pbBU Partnership Platform Enablement /b /p ul liPartner with each BU to translate domain‑specific needs into shared workflows and platform capabilities; BUs own clinical value and specialization; this role owns platform enablement and cross‑BU reuse. /li liCo‑create packaged solutions that combine BU specialization with the digital platform (connectivity, data, analytics, remote service) to deliver measurable outcomes. /li liIdentify regulatory and cybersecurity strategies that could be harmonized across BUs using shared processes and artifacts. /li /ul pbPartnership with Business Units Governance /b /p pThis role is working in close partnership with each Business Unit. The BU owns clinical specialization and value—defining domain‑specific use cases, clinical outcomes, evidence generation, and alignment with the BU’s strategy. The Senior Director owns cross‑BU workflow design, the shared digital platform, and related enterprise‑scale capabilities, ensuring alignment with Werfen’s digital strategy. /p pbRACI at a Glance /b /p ul liBusiness Units (Own): clinical specialization, value propositions, domain use cases, clinical evidence, KOL engagement, and BU‑aligned positioning. /li liSenior Director (Own): cross‑BU workflow orchestration, shared data analytics and, in collaboration with RD teams, identify common platform capabilities, interoperability standards/APIs, identity/security/privacy controls, DevOps/SRE, and design system. /li liJoint (Shared): portfolio and roadmap prioritization, business cases, GTM readiness, packaged offerings, and post‑market surveillance/continuous improvement. /li /ul pbScope of Platform Related Activities (Examples) /b /p pIn collaboration with RD, Cybersecurity, QA and RA: /p ul liWorkflow orchestration across analyzers, middleware, LIS/EHR, and cloud services. /li liConnectivity interoperability: HL7 v2, ASTM/POCT1‑A, FHIR APIs, partner SDKs, developer portal and sandbox. /li liDevice onboarding/provisioning, remote service telemetry, predictive maintenance models. /li liCommon data platform: streaming pipelines, lakehouse/warehouse, semantic models (e.g., LOINC mapping), data governance/MDM. /li liAnalytics decision‑making services: QC analytics, operational dashboards, capacity forecasting, AI/ML model lifecycle (MLOps). /li liUnified UX: component library/design system for consistent clinician and lab experiences. /li liSecurity privacy by design: identity/access (RBAC), consent, audit, SBOMs, vulnerability and patch management, secure software updates (OTA). /li liCloud/edge operations: observability, SLOs/SLAs, incident management, continuous delivery, automated testing and validation. /li liRegulatory enablement: shared IEC 62304/ISO 14971/ISO 13485 artifacts, cybersecurity documentation, labeling/UDI support, /li /ul pIn collaboration with commercial teams: /p ul liCommercial enablement: packaging and pricing for platform + BU offerings (SaaS/subscription/outcome‑based), telemetry for value realization /li /ul pbAlignment with Werfen Digital Strategy /b /p ul liConverge BU‑specific roadmaps onto a common platform that accelerates reuse and time‑to‑value. /li liAdopt enterprise principles: interoperability‑first, security‑ and privacy‑by‑design, cloud‑first/edge‑aware, data ethics and compliance. /li liDefine cross‑BU KPIs (e.g., instrument uptime, TAT improvement, workflow automation rates, platform adoption). /li liLead Digital Architecture Council with BU product‑and engineering leaders to govern standards, APIs, and shared services. /li /ul h3Qualifications /h3 pbEducation Experience /b /p ul liBachelor’s degree in engineering, Computer Science, Biomedical Engineering, or related field (Master’s or MBA preferred). /li li12–15 years in digital product management/innovation for medical devices or healthcare tech, with at least 7–10 years specifically in IVD. /li liProven track record launching regulated, commercial IVD digital products (middleware, connectivity, remote diagnostics/service, analytics) at scale. /li liDeep fluency with lab workflows and connectivity standards (HL7 v2, ASTM/POCT1‑A, FHIR) and integration to LIS/EHR ecosystems. /li liExperience across the full IVD lifecycle: design controls, verification/validation in clinical settings, submission support, and post‑market surveillance. /li /ul pbSkills Attributes /b /p ul liStrategic thinker balancing technical depth with commercial and operational acumen. /li liExpertise in agile product development, user‑centered design, and innovation frameworks (Design Thinking, Lean Startup). /li liAbility to convert complex clinical and technical concepts into clear business value propositions and outcomes. /li liExceptional communication and stakeholder management across RD, regulatory/quality, services, and commercial leadership. /li liPassion for transforming diagnostics through data, automation, and interoperable digital ecosystems. /li /ul pbManaging Work /b Effectively managing one’s time and resources to ensure that work is completed efficiently. /p pbEmotional Intelligence Essentials /b Establishing and sustaining trusting relationships by accurately perceiving and interpreting own and others’ emotions and behavior; leveraging insights to effectively manage own responses so that one’s behavior matches one’s values and delivers intended results. /p pbBuilding Partnerships /b Developing and leveraging relationships within and across work groups, including cross‑functional groups, to achieve results. /p pbDecision Making /b Identifying and understanding problems and opportunities by gathering, analyzing, and interpreting quantitative and qualitative information; choosing the best course of action by establishing clear decision criteria, generating and evaluating alternatives, and making timely decisions; taking action that is consistent with available facts and constraints and optimizes probable consequences. /p pbContinuous Improvement /b Originating action to improve existing conditions and processes; identifying improvement opportunities, generating ideas and implementing solutions. /p pbContinuous Learning /b Actively identifying new areas for learning; regularly creating and taking advantage of learning opportunities; using newly gained knowledge and skill on the job and learning through their application. /p pIf you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV. /p pWerfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V. /p /p #J-18808-Ljbffr