Solution Leader, Werfen ActiveConnect

Introduction

Werfen

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

Job 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.

What success looks like

In the first 90 days, you own the backlog and release plan, are running refinement and sprint planning with the Scrum teams, have working relationships with the affiliate champions and business-unit counterparts, and have published a prioritized roadmap with clear decision rights.

Within six months, ActiveConnect is live and stable at customer sites across more than one instrument family and region, with an agreed support model and success measures reported monthly.

Within twelve months, the next major release has shipped on schedule, rollout is expanding across affiliates, and the product’s adoption and service value are measurable and visible to leadership.

Preferred Experience:

• Hands-on software product management. You have personally written requirements, user stories and acceptance criteria, run backlog refinement and sprint planning with Scrum teams (Jira, Confluence or similar), and taken software changes through a controlled change and release process: change requests, impact analysis, versioning, traceability and release notes.
• Demonstrated success leading without authority in a global matrix with international affiliates or regional business units.
• Experience releasing software in a regulated environment, preferably medical devices or in vitro diagnostics, under IEC 62304, ISO 13485 or equivalent design controls.
• Working knowledge of cloud-hosted products (AWS preferred) and enough fluency in networking and security concepts to hold a credible conversation with hospital IT and security teams.
• Practical understanding of healthcare data protection and cybersecurity expectations, including HIPAA, GDPR and FDA premarket cybersecurity guidance
• Hands-on experience deploying virtualized infrastructure (for example VMware vSphere/ESXi or Hyper-V virtual appliances) in customer or hospital networks, including the network, firewall and certificate configuration that goes with it.
• Experience with field service organizations, service operations or remote-service platforms for capital equipment.
• Familiarity with clinical laboratory workflows and laboratory instrument connectivity.
• MBA or equivalent business training.

Qualifications

Minimum Knowledge & Experience Required for the Position:

• Bachelor's Degree in Biological Science, Engineering or Business Administration, or equivalent
• 3-5 years of relevant work experience, within the healthcare industry preferred
• 2+ years of relevant work experience with agile and scrum, preferred
• MBA, preferred

Skills & Capabilities

Domain Expertise:

• Proven knowledge of standard concepts, practices, and procedures within the relevant industry
• Strong collaborator with experience working in cross-functional teams from tech, design, and business
• Experience with B2C digital products
• Understanding and knowledge of various roles in regulated industries and how they interact with product offering
• Understanding of laboratory and clinical workflows as it pertains to diagnostics preferred

Agile/Digital Experience:

• Experience in facilitating agile ceremonies, managing a backlog/release plan, tracking team level metrics, removing blockers (burndown chart, release burn up, etc.), preferred
• Experience in leading teams, preferably in an agile setting

Individual Skills:

• Strong leader, collaborator, team player, and individual contributor
• Strong communication skills with comfort in speaking with business and technical stakeholders
• Strong problem solver with the ability to manage and lead the team to push the solution and progress

Mindset and Behaviors:

• Passion to challenge the status quo and find new solutions and drive out of the box ideas - loves and embraces change
• Believes in a non-hierarchical culture of collaboration, transparency, safety, and trust
• Not afraid to "roll up the sleeves" and seeks to go outside comfort zone to learn -pushes teams to do the same
• Empowers others to fail, learn, and grow
• Experimental mindset to drive innovation

Travel Requirements:

• Up to 15% of the time.

The annual base salary range for this role is currently $160,000 to $195,000. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

Closing

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com