Director of Systems Engineering

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
• External development partners
• Transfusion Leadership Team

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…