Werfen

Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories.  The Company’s business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing.  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.

Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA.  Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA.  Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.

Job Summary:

Werfen's Digital Solutions organization is building a next-generation, event-driven middleware platform that will become the common connectivity and data backbone for our diagnostics product lines (acute care, coagulation, autoimmunity, and future product lines such as transplant). The Principal Software Engineer will provide hands-on technical leadership for the Device Connectivity workstream — architecting and building the systems that connect a wide range of laboratory and point-of-care devices to the platform, and helping define the canonical data model, event backbone, and cloud-native infrastructure the whole platform is built on.

This is a high-ownership role for someone who has designed distributed, event-driven systems in production, is comfortable operating close to hardware/device protocols as well as cloud infrastructure, and can lead a small team while remaining hands-on.

Key Accountabilities

Essential Functions:

• Provide technical leadership for the Device Connectivity workstream: own architecture, design, and delivery for connecting diagnostic devices to the middleware platform.
• Design and implement device connectivity services using industry protocols including ASTM E1381/E1394, POCT1-A2, HL7, and MQTT.
• Architect event-driven, distributed backend systems — events as the sole transport between platform and product databases, with no cross-database joins.
• Design and build on AWS serverless architecture (e.g., Lambda, API Gateway, EventBridge/Kinesis, SQS/SNS), with data infrastructure on AuroraDB and S3.
• Own IoT/device-fleet concerns: real-time telemetry ingestion, device state and status modeling, connectivity resilience, and edge-vs-cloud trade-offs.
• Contribute to canonical data model design across device, order, result, QC, and reagent/consumable domains, identifying and resolving structural gaps between device specs and the shared model.
• Apply distributed systems fundamentals (replication, consistency, delivery guarantees, fault tolerance) to platform decisions such as read routing and data durability.
• Lead, mentor, and review the work of other engineers; participate in and help shape hiring for the team.
• Partner with architects and stakeholders across the Digital Solutions initiative, the Device organization, and product teams to align on roadmap and platform/application boundaries.
• Ensure application performance, uptime, scalability, security, and compliance appropriate to a regulated healthcare/IVD environment.
• Use agile engineering practices to deliver incrementally and collaborate closely with cross-functional squad members.

Networking/Key Relationships:

• Works closely with the Device Connectivity and Digital Solutions leadership, the Device team (device roadmap and specifications), and engineers across the shared middleware platform and individual products (GWP, HemoHub, QuantaLink, and future products).

Minimum Knowledge & Experience Required for the Position:

• Bachelor's Degree plus a minimum of 10 years related experience or Master's Degree plus 8 year of related experience or waiver based on experience
• Experience in Software Medical Devices development that follows ISO 13485, IEC 62304 / 21 CFR Part 820.30 highly desired
• Proven experience leading architecture and delivery of event-driven, distributed backend systems in production

Skills & Capabilities

Domain Expertise:

• Deep, hands-on experience with event-driven architecture and asynchronous messaging (e.g., Kafka, EventBridge, SNS/SQS, MQTT).
• Strong grounding in distributed systems fundamentals: replication, partitioning, consistency models, delivery guarantees, and failure handling.
• Hands-on AWS serverless experience: Lambda, API Gateway, Step Functions, EventBridge/Kinesis, SQS/SNS, DynamoDB/Aurora, S3, Cognito or similar.
• Experience with IoT or device connectivity — ingesting and normalizing data from distributed device fleets; experience with healthcare/lab device protocols (ASTM, POCT1-A2, HL7) is a strong plus.
• Microservices architecture and domain-driven design; comfort defining bounded contexts and canonical data models across previously siloed systems.
• Strong backend development skills (e.g., Java/Spring, Node.js, or Python) and experience with both SQL and NoSQL data stores.
• Working knowledge of containerization and infrastructure automation (Docker, Kubernetes, IaC).
• Ability to write and champion effective unit, integration, and contract tests for distributed systems.
• Experience in a regulated environment (healthcare, IVD, or similarly compliance-heavy industry) is a plus, including awareness of audit and traceability requirements.

Agile/Digital Experience:

• Strong understanding of agile methodologies and experience working within cross-functional agile teams.
• Experience leading or tech-leading a squad or workstream preferred.

Individual Skills:

• Strong communication skills, with the ability to explain complex distributed-systems trade-offs to both engineers and non-technical stakeholders.
• Sound problem-solving skills with the ability to quickly process complex information and present it clearly.
• Comfortable driving technical decisions under ambiguity, and documenting the reasoning for future teams.

Mindset and Behaviors:

• Passionate about distributed systems and event-driven architecture, and energized by modernizing legacy platforms.
• Self-starter who can operate with minimal supervision while keeping stakeholders aligned.
• Believes in transparency, direct feedback, and shared technical ownership.
• Open to learning new domains — this role spans device protocols, cloud infrastructure, and healthcare data standards.

Travel Requirements:

• None
  

The annual base salary range for this role is currently $150,000 to $185,000. 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.

www.werfen.com

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