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.

We are seeking a Staff Systems Architect to lead the systems design for next generation Hemostasis products.  The ideal candidate will have deep expertise in IVD systems development, with hands-on knowledge of systems like the ACL TOP automated coagulation and hemostasis analyzer (or similar).  This role will shape next generation system architecture - aligning, optical, mechanical, electrical, process-development, and software discipline and will ensure robust performance, reliability, scalability, and regulatory compliance of IVD system solutions.  The candidate will drive cross functional collaboration, define system requirements, and ensure integration across hardware, software, and reagents. Candidates should bring strong leadership in complex medical device/instrumentation development, a track record of systems level risk management, and a strategic mindset for product innovation.  Candidates must possess a demonstrated ability to communicate complex technical details into clear, actionable business decisions.  A proven track record in mentoring and developing technical talent is a must.  Candidates should excel at orchestrating complex project milestones, ensuring alignment between R&D, regulatory, and commercialization teams – demonstrating efficient bottoms-up planning and proactive risk mitigation.  

Key responsibilities 

• Lead system architecture and technical strategy for complex medical device and IVD platforms, with a focus on hardware and electromechanical systems. 

• Translate customer needs, intended use, assay performance requirements, and regulatory needs into system requirements, user workflows, architecture, and defined subsystem interfaces.  

• Drive cross-functional technical decisions, trade-off analysis, architecture reviews, and risk assessment across hardware, firmware, software, and system engineering.  

• Define system integration, verification, validation and reliability strategies in alignment with applicable medical device regulations and design controls 

• Govern system architecture documentation, requirement baselines, interface specifications, and engineering changes through structural configuration management, impact assessments, and design reviews in accordance with design control. 

• Identify and mitigate technical risks, mentor engineering teams, and promote system engineering best practices. 

• Ensure system architecture and development deliverables align with applicable medical device and IVD regulations and standards, including FDA Quality Management Systems Regulations, (ISO: 13485, 14971), IEC 62304 for software lifecycle processes, IEC 62366/HE75 and EU IVDR. 

Leadership, Communication & Stakeholder Influence 

• Demonstrates executive presence, strong communication skills, and the ability to articulate technical decisions, trade-offs, and recommendations clearly to technical and business audiences.
• Builds cross-functional alignment, influences stakeholders, and supports engineering leaders in driving consensus on architecture, priorities, and technical direction. 
•  Exercises sound technical judgment, remains composed under pressure, and communicates confidently and professionally in high-stakes technical reviews and customer facing situations. 
•  Represents the system engineering organization with credibility, accountability, and a collaborative, solutions-oriented mindset. 

Minimum Knowledge & Experience Required for the Position:

• Master's Degree in Engineering or equivalent scientific discipline and 12 plus years of experience or an equivalent combination of education and experience.
• Recognized authority for broad engineering program areas or in an intensely specialized area of considerable novelty and importance
• Proven track record of leading products from concept through commercialization.
• Proven track record of leading products from concept through commercialization.
• Strong expertise in:
• Quality systems and design controls (ISO 13485, US FDA 21 CFR Part 820) 
• Medical device hardware platform architecture
• Electronics and embedded systems design
• Electromechanical product development (IEC 61010, IEC 62326)
• System engineering principles and architecture methodologies (INCOSE membership a plus) 
• Requirements management and traceability 
• Usability Engineering (IEC 62366) and Human Factors 
• Risk management (ISO-14971), reliability engineering, and DFMEA 
• Design controls, verification, and validation 
• Experience making architecture decisions across multidisciplinary engineering organizations. 
• Experience in Software Development Lifecycle (SDLC) and SW Cybersecurity – IEC 62304, IEC 82304-1, IEC 81001-5-1 
• Strong understanding of FDA, MDR, IVDR, IEC, ISO, and other applicable medical device standards.  

International Mobility: Required:

• No

Travel Requirements: 

• <5% of time

Pay Transparancy Language

The annual base salary range for this role is currently $205K to $245K range. 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.

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