Director of Systems Engineering

Country

United States

Shift

1st

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.

Job Summary

The Director of Systems Engineering provides strategic and technical leadership for the Systems Engineering function, leading the development and integration of on market and new product medical device systems from concept through commercialization. This role builds organizational capability, drives systems engineering excellence, and ensures customer, business, technical, and regulatory requirements are translated into innovative and marketable products.

Key Accountabilities

• Provide strategic leadership and direction for a multidisciplinary team of scientists and technologists, fostering a high-performance culture, organizational alignment, and strong talent development pipeline.
• Build a strong team and create a culture of accountability, ownership, integrity, and innovation
• Establish and maintain governance frameworks to ensure compliance with all organizational policies, quality systems, regulatory requirements, and industry standards applicable to R&D activities.
• Lead functional strategy and capability development, ensuring alignment with business objectives while driving execution of organizational priorities and long-term innovation goals.
• Champion scientific excellence by developing organizational capabilities, promoting advanced scientific and statistical methodologies, and ensuring adoption of industry best practices across teams.
• Oversee the review and approval of design and development documentation, ensuring technical rigor, regulatory compliance, and alignment with quality and business objectives.
• Direct and manage strategic relationships with external development partners, ensuring alignment on scope, deliverables, timelines, and investments while proactively addressing risks and changes.
• Provide executive oversight for project and product risk management activities, ensuring timely identification, assessment, mitigation, and escalation of key technical and business risks.
• Leverage deep expertise in mechanical systems, fluidics, electronics, and medical device technologies to guide technical strategy, innovation, and decision-making across development programs.
• Serve as a key stakeholder in portfolio planning and governance, providing strategic direction for design and development activities to ensure successful execution of project objectives.
• Drive the development of innovative testing capabilities, infrastructure, and methodologies that support product characterization, verification, validation, and commercialization efforts.
• Provide leadership in evaluating technology feasibility, product performance, and system capabilities to support investment decisions, product strategy, and development roadmaps.
• Champion data-driven decision-making by ensuring robust experimental design, statistical analysis, and interpretation of results across development programs to accelerate product innovation and continuous improvement.
• Perform other duties and responsibilities as assigned
  
  Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key relationships

• R&D, R&D Reagent & Assay Development, Marketing, Operations, QA/RA
• PMO

Minimum Knowledge & Experience required for the position:

• Bachelor’s degree in engineering required; advanced degree (M.S. or Ph.D.) in Engineering, Systems Engineering, Biomedical Engineering, or related discipline strongly preferred.
• Minimum of 15 years of progressive engineering experience, including at least 12 years within the medical device…