Bachelor's degree in engineering required; advanced degree preferred.
15+ years of progressive engineering experience, with 12+ years in the medical device industry.
Proven ability to communicate complex technical concepts to diverse stakeholders.
Exceptional analytical and problem-solving skills in systems engineering and product development.
Extensive experience in developing complex medical device systems, including hardware and software.
Responsibilities
Provide strategic leadership for a multidisciplinary team, fostering a high-performance culture.
Build a strong team and promote accountability, ownership, and innovation.
Establish governance frameworks for compliance with policies and regulatory requirements.
Lead functional strategy and capability development aligned with business objectives.
Oversee design and development documentation to ensure technical rigor and compliance.
Manage strategic relationships with external partners, addressing risks and changes proactively.
Drive innovative testing capabilities to support product commercialization efforts.
Benefits
Comprehensive health and wellness programs.
Professional development opportunities and training.
Flexible work arrangements and work-life balance initiatives.
Retirement savings plans with company matching.
Employee assistance programs for personal and professional support.
Full Job Description
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 assigned Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
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%
About Instrumentation Laboratory Company
Instrumentation Laboratory Company (IL) is a global leader in the development, manufacturing and distribution of diagnostic solutions for Acute Care Diagnostics, with a focus on Critical Care and Hemostasis testing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. IL develops, manufactures and distributes diagnostic solutions including: critical care systems, hemostasis systems and information management systems. IL's products are used in hospitals around the world, including large hospital systems, independent hospitals and clinics, and reference laboratories. IL is headquartered in Bedford, Massachusetts, and has operations in Europe, the Middle East, Africa, Asia-Pacific, and Latin America.
