Senior Staff Software Engineer, R&D

The Senior Staff Software Engineer is a senior technical leader and individual contributor responsible for the architecture, design, implementation, and delivery of complex software for medical and connected device products. The engineer operates across real-time embedded systems, device connectivity and management, application software, and system interfaces; translates ambiguous product and system needs into robust technical solutions; and influences decisions across functions and projects. The Senior Staff Software Engineer remains technically hands-on while mentoring engineers, raising engineering standards, and helping teams make sound decisions under technical, regulatory, quality, and schedule constraints., * Lead the architecture, design, and implementation of complex software subsystems and reusable platform capabilities across embedded, application, and connected-device domains.

• Own key technical decisions and ensure designs are coherent at the product and system level.
• Work hands-on in the design, implementation, and review of critical software, with particular depth in C/C++, embedded Linux and/or RTOS environments, real-time behavior, concurrency, memory/resource constraints, robustness, and maintainability.
• Define and evolve software approaches for secure device connectivity, communications, device identity and configuration, diagnostics and logging, software update and serviceability, and device/fleet management capabilities as applicable to the product.
• Manage software lifecycle deliverables and traceability from system and software requirements through architecture, detailed design, implementation, risk controls, verification/validation, release, and post-release change.
• Apply company quality processes and design controls while partnering with Quality, Systems Engineering, and System Verification to address software risk, reliability, cybersecurity, objective evidence, and applicable FDA, IVDR, and international regulatory expectations.
• Lead technical problem solving across Software, Systems, Electrical/Hardware, Quality, Verification, Product, Service, and other functions.
• Resolve interface and architectural issues while balancing product needs, technical constraints, regulatory obligations, and delivery commitments.
• Identify emerging product needs, architectural weaknesses, and technical debt; evaluate or prototype alternatives; and introduce practical innovations that improve capability, reuse, extensibility, reliability, serviceability, security, or engineering effectiveness.
• Provide technical estimates, identify dependencies and risks, shape implementation strategies, and help teams make timely tradeoffs when requirements are incomplete or changing.
• Mentor and coach engineers, strengthen architecture, design, andcode reviews, contribute to technical hiring, and help maintain a collaborative and accountable engineering culture.

Networking/Key relationships

• Software Engineering
• Systems Engineering
• Electrical / Hardware Engineering
• Quality Engineering
• System Verification
• Product Management / Product Development
• Regulatory, Service, Operations, and other cross-functional stakeholders as required

• BS/BA degree in Computer Science, Computer Engineering, Electrical Engineering, or a closely related technical field required; advanced degree is a plus.
• Minimum twelve (12) years of professional software development experience with complex embedded, connected, or software-intensive products
• Experience working within formal product-development and design-control processes for medical devices or comparable regulated/safety-critical systems Direct medical-device or in-vitro diagnostic software experience is preferred.
• Proficiency in C and C++ with practical experience in embedded Linux and/or RTOS-based system Demonstrated.
• Experience designing or delivering network-connected devices and related capabilities such as secure communications, network interfaces, diagnostics, configuration, software update, serviceability, and device management concepts.

Skills & Capabilities:

• Demonstrated technical leadership skills, including mentoring engineers, driving alignment, and influencing architectural decisions.
• Solid understanding of design methods (e.g., OOD, UML) and software architecture principles, including modular design, abstraction, interface-based design, and reusable software frameworks.
• Understanding of software architectural challenges when designing embedded systems and connected products.
• Ability to estimate work durations based on high-level requirements and system constraints.
• Advanced understanding of real-time software concepts on embedded Linux or RTOS platforms, including deterministic behavior, multi-threaded applications, synchronization, fault handling, memory management, and interprocess communication.
• Ability to develop clear, testable software requirements from product and system-level requirements, including support for traceability, risk analysis, and regulated development processes.
• Highly skilled in ANSI C and C++.
• Scripting expertise with Python or similar language.
• Networking experience, including TCP/IP, NAT, Layer 2 Switching, Firewalls, DHCP, device communications, security, diagnostics, and remote device management concepts.
• Experience with software development tools and practices, including Git, Bitbucket, Jenkins, JIRA, code reviews, CI/CD, defect tracking, and configuration management.
• Experience with Qt or similar application/UI frameworks is a plus.
• Excellent written and verbal communication skills, with the ability to communicate technical concepts, risks, and recommendations to both technical and non-technical stakeholders.

The annual base salary range for this role is currently $185,000 to $210,000. This is a bonus-eligible position. 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.

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., 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.