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Solution Leader, Werfen ActiveConnect at Werfen GmbH, Bedford, MA

Solution Leader, Werfen ActiveConnect at Werfen GmbH in Bedford, MA. Full-time. Apply with swipeandhired.

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.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Overview

J o b Summary:

Werfen ActiveConnect is Werfen’s cloud-based connected-service platform. It links our Hemostasis, Acute Care and Autoimmunity analyzers in customer laboratories to Werfen’s global service organization through an on-premise gateway installed in the customer’s network, enabling secure remote access, remote software delivery and on-demand retrieval of instrument logs. It is a multi-tenant SaaS product built on AWS, designed with data minimization, tenant isolation and data residency at its core, and released under medical-device software controls.
The platform has completed its first controlled release and is moving into customer deployment across multiple product lines and regions. We are looking for a Solution Leader who will own ActiveConnect end to end : its vision and roadmap, each release, its launch and adoption across affiliates, and its transition into a governed, scalable operation. This is a product-ownership role, not a support role. You will decide what the product does next, defend those decisions with data, and be accountable for whether customers and service teams actually use it.
You will report to the Expert Solution Leader, Cloud Platforms, and work across a wide matrix: the Digital Factory engineering teams, R&D and Quality/Regulatory in the business units that manufacture the connected instruments, Global Service and Support, commercial affiliates, IT, Cybersecurity and the Global Privacy Office.

Responsibilities

Key accountabilities
Product Ownership Roadmap

Own the ActiveConnect product vision and multi-release roadmap, and prioritize the backlog across business units, affiliates and service needs. Say no with a rationale, and keep one source of truth for priorities and decisions.
Requirements. Translate field-service and customer needs (remote troubleshooting, complaint-related log retrieval, software and patch delivery, remote access) into clear, testable requirements, working with Scrum teams, architects and business analysts.
Interoperability. Own the compatibility matrix between ActiveConnect and the instrument and middleware software versions it supports, and align ActiveConnect releases with the independent release cadences of each business unit.

Delivery

Backlog and sprint planning. Break approved product and software requirements into user stories and technical tasks with clear, testable acceptance criteria, sized and sequenced for upcoming sprints. Lead backlog refinement and sprint planning with the Scrum teams, keep work refined at least one sprint ahead, and set sprint goals that move the release plan forward.
Progress and feature completion. Track sprint and release progress against plan . Report feature completion, scope changes, slipped work and delivery risk to stakeholders and leadership, with a recommendation attached, not only a status.
Verification and validation. Make sure every requirement is traced to verification and covered by it. Review verification results and open anomalies with engineering and QA. Lead product-level validation against user needs, including with service and affiliate users, before release. Confirm release readiness: requirements traced to passing tests, anomalies assessed and dispositioned, release documentation complete.

Regulated Release

Design controls. Lead the product’s inputs to the software lifecycle under IEC 62304 and ISO 13485: requirements, risk management contributions, release documentation and labeling, including the cybersecurity and privacy guide that ships with the product.
Cybersecurity and privacy. Partner with Cybersecurity, GRC and the Global Privacy Office to define and meet security, privacy and data-protection requirements (HIPAA, GDPR, FDA cybersecurity guidance, customer data processing agreements) for each release and each new territory .
Customer IT acceptance. Equip affiliates to pass hospital IT and security reviews: network and connectivity requirements, security questionnaires, and the documentation customers need to authorize installation.

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