Director of Systems Engineering

Werfen • Norcross, GA

2d

About The Position

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. The role builds organizational capability, drives systems engineering excellence, and ensures customer, business, technical, and regulatory requirements are translated into innovative, marketable products.

The Director leads a multidisciplinary team and develops functional strategy, governance, talent, and capabilities in alignment with business objectives and long-term innovation goals. The role oversees design and development documentation, technical and regulatory rigor, project and product risk management, and strategic relationships with external development partners. It also guides technical strategy across mechanical systems, fluidics, electronics, and medical device technologies; contributes to portfolio planning and governance; and advances testing capabilities and data-driven product development.

The position works with R&D, reagent and assay development, Marketing, Operations, QA/RA, the PMO, external development partners, and the Transfusion Leadership Team. Travel requirements are up to 15%.

Requirements

• Bachelor’s degree in engineering required; relevant work experience may be substituted for a degree at management’s discretion.
• At least 15 years of progressive engineering experience, including at least 12 years in the medical device industry, and demonstrated success leading complex systems development organizations and cross-functional product development programs; management may make exceptions to the years-of-experience requirement.
• Ability to communicate complex technical concepts, system-level tradeoffs, and strategic recommendations to executive leadership, cross-functional stakeholders, and external partners.
• Strong analytical, critical-thinking, and problem-solving skills, with expertise in systems engineering principles, product development processes, and technical decision-making across complex product portfolios.
• Experience leading development of complex medical device systems, including hardware, software, automation, fluidics, electronics, and integrated system solutions.
• Knowledge of medical device regulations and quality systems, including FDA requirements, ISO standards, GMP guidelines, design controls, and product lifecycle management processes.
• Experience leading multiple programs and engineering resources simultaneously, with portfolio management, prioritization, and organizational leadership skills.
• Experience driving Design for Six Sigma (DFSS), systems thinking, and quality-by-design methodologies.
• Expertise translating customer, clinical, business, and regulatory needs into system requirements, architectures, and product strategies.
• Experience leading systems architecture, requirements management, system modeling, simulation, verification, and validation throughout the product development lifecycle.
• Knowledge of design transfer and cross-functional integration for transition from development through manufacturing, launch, and sustainment.
• Expertise in systems-level risk management, including risk assessment, mitigation, and decision-making compliant with applicable standards and regulations.
• Experience defining and executing systems engineering strategies, processes, tools, and organizational capabilities.
• 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.
• Strong understanding of regulatory requirements, development of IVD automated testing systems, and design control processes including requirements development and risk management.
• Strong leadership skills and the ability to attract and develop talent.

Nice To Haves

• An M.S. or Ph.D. in Engineering, Systems Engineering, Biomedical Engineering, or a related discipline is strongly preferred.

Responsibilities

• Provide strategic leadership and direction for a multidisciplinary team of scientists and technologists, fostering a high-performance culture, organizational alignment, and talent development.
• Build a strong team and promote accountability, ownership, integrity, and innovation.
• Establish and maintain governance frameworks that support compliance with organizational policies, quality systems, regulatory requirements, and industry standards for R&D activities.
• Lead functional strategy and capability development in alignment with business objectives, organizational priorities, and long-term innovation goals.
• Develop organizational scientific capabilities, promote advanced scientific and statistical methodologies, and encourage adoption of industry best practices.
• Oversee the review and approval of design and development documentation for technical rigor, regulatory compliance, and alignment with quality and business objectives.
• Manage strategic relationships with external development partners, aligning scope, deliverables, timelines, and investments and addressing risks and changes.
• Provide executive oversight of project and product risk management, including identification, assessment, mitigation, and escalation of key risks.
• Apply expertise in mechanical systems, fluidics, electronics, and medical device technologies to guide technical strategy, innovation, and development decisions.
• Participate in portfolio planning and governance, providing strategic direction for design and development activities.
• Drive development of testing capabilities, infrastructure, and methodologies for product characterization, verification, validation, and commercialization.
• Evaluate technology feasibility, product performance, and system capabilities to support investment decisions, product strategy, and development roadmaps.
• Promote data-driven decisions through robust experimental design, statistical analysis, and interpretation of results across development programs.
• Perform other duties and responsibilities as assigned.
• Travel up to 15%.

What This Job Offers

• Job Type: Full-time
• Career Level: Director