Job Information
About the Position
Introduction
Werfen 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.
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.
•Translate clinical functionality and operational needs, defined with the business units, into scalable and harmonized platforms and 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.
•Own adoption and monetization strategies (e.g., SaaS, subscription, outcome-based models) and partner with commercial and customer service- and success teams.
IVD Domain Leadership & Compliance
•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.
Leadership & Collaboration
•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.
•Communicate strategy, progress, and outcomes to the executive team and broader organization.
BU Partnership & Platform Enablement
•Partner 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.
•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.
Partnership with Business Units & Governance
This 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.
RACI at a Glance
•Business Units (Own): clinical specialization, value propositions, domain use cases, clinical evidence, KOL engagement, and BU-aligned positioning.
•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.
•Joint (Shared): portfolio and roadmap prioritization, business cases, GTM readiness, packaged offerings, and post-market surveillance/continuous improvement.
Scope of Platform & Related Activities (Examples)
In collaboration with R&D, Cybersecurity, QA and RA:
•Workflow orchestration across analyzers, middleware, LIS/EHR, and cloud services.
•Connectivity & interoperability: HL7 v2, ASTM/POCT1-A, FHIR APIs, partner SDKs, developer portal and sandbox.
•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.
•Analytics & decision-making services: QC analytics, operational dashboards, capacity forecasting, AI/ML model lifecycle (MLOps).
•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
•Converge BU-specific roadmaps onto a common platform that accelerates reuse and time-to-value.
•Adopt enterprise principles: interoperability-first, security- and privacy-by-design, cloud-first/edge-aware, data ethics and compliance.
•Define cross-BU KPIs (e.g., 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.
Qualifications
Education & Experience
•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.
•Deep fluency with lab workflows and connectivity standards (HL7 v2, ASTM/POCT1-A, FHIR) and integration to LIS/EHR ecosystems.
•Experience across the full IVD lifecycle: design controls, verification/validation in clinical settings, submission support, and post-market surveillance.
Skills & Attributes
•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).
•Ability to convert complex clinical and technical concepts into clear business value propositions and outcomes.
•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.
Travel requirements:
>40%
Individual Contributor Core Competencies:
Managing Work Effectively managing one’s time and resources to ensure that work is completed efficiently.
Emotional Intelligence Essentials 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.
Building Partnerships Developing and leveraging relationships within and across work groups, including cross-functional groups, to achieve results.
Decision Making 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.
Continuous Improvement Originating action to improve existing conditions and processes; identifying improvement opportunities, generating ideas and implementing solutions.
Continuous Learning 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.
If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV.
Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V.
www.werfen.com
