Director of Systems Engineering

Introduction

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

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.

Responsibilities

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 assignedReasonable 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
• External development partners
• Transfusion Leadership Team

Qualifications

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 industry and demonstrated success leading complex systems development organizations and cross-functional product development programs.
• Proven ability to communicate complex technical concepts, system-level tradeoffs, and strategic recommendations to executive leadership, cross-functional stakeholders, and external partners.
• Exceptional analytical, critical thinking, and problem-solving skills, with demonstrated expertise in systems engineering principles, product development processes, and technical decision-making across complex product portfolios.
• Extensive experience leading the development of complex medical device systems, including hardware, software, automation, fluidics, electronics, and integrated system solutions.
• Deep knowledge of medical device regulations and quality systems, including FDA requirements, ISO standards, GMP guidelines, design controls, and product lifecycle management processes.
• Demonstrated success leading multiple programs and engineering resources simultaneously, with strong portfolio management, prioritization, and organizational leadership skills.
• Experience driving Design for Six Sigma (DFSS), systems thinking, and quality-by-design methodologies to ensure robust product development and successful commercialization outcomes.
• Expertise in translating customer, clinical, business, and regulatory needs into system requirements, architectures, and product strategies.
• Demonstrated experience leading systems architecture, requirements management, system modeling, simulation, verification, and validation activities across the product development lifecycle.
• Strong knowledge of design transfer processes and cross-functional integration to ensure successful transition from development through manufacturing, launch, and sustainment.
• Recognized expertise in systems-level risk management, including development and execution of risk assessment, mitigation, and decision-making processes in compliance with applicable standards and regulations.
• Experience defining and executing systems engineering strategies, processes, tools, and organizational capabilities that support innovation and business growth.
• Demonstrated ability to influence technology roadmaps, product portfolio decisions, and long-term engineering investments through strategic leadership and technical vision.
• Experience building, developing, and leading high-performing systems engineering teams, including talent development, succession planning, and organizational capability enhancement.
• Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:

• Strong understanding of regulatory requirements
• Strong understanding of development of IVD automated testing systems
• Strong understanding of design control processes including requirements development and risk management.
• Strong leadership skills with capability to attract and develop talent

Travel requirements:

Up to 15%

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 [email protected] 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