Principal System Engineer

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Location
:
Libertyville
Department
:
Research & Development

The Principal Systems Engineer leads technical efforts to develop new medical device products from concept through commercialization. Operating at the Lead Practitioner level within the INCOSE Systems Engineering Competency Framework, this role applies holistic systems thinking, advanced risk management, and technical leadership to ensure that safe, effective, and compliant products are delivered on time and within budget. The Principal Systems Engineer collaborates early and often across mechanical, electrical, software, quality, regulatory, and manufacturing functions to define requirements, develop system architectures, perform risk analysis, and drive system verification and validation throughout the product development lifecycle.

Beginning May 4th, all Hollister Associates will be coming into the office a minimum of 4 days per week.

• Lead the identification, elicitation, and prioritization of stakeholder needs, user needs, and design inputs in compliance with FDA 21 CFR 820.30 Design Controls.
• Create, manage, and maintain product- and system-level requirements (including functional, performance, safety, regulatory, and usability requirements), ensuring full traceability through the Design History File (DHF).
• Develop use cases, use scenarios, and operational concepts based on clinical workflows, user environments, and the product’s intended use.
• Drive requirements-driven design by flowing system-level requirements down to subsystem and component levels, defining clear boundary conditions and acceptance criteria.
• Develop and maintain system architectures for devices and device family derivatives, aligned with platform development goals and product/technology strategies.
• Define system boundaries, interfaces, and allocation of functions and performance.
• Apply model-based systems engineering (MBSE) approaches and tools (e.g., DOORS, Jama, Polarion) to manage complexity and support decision-making.
• Support development of the Risk Management File in accordance with ISO 14971, including hazard identification, risk estimation, risk evaluation, risk control, and residual risk assessment.
• Lead system-level DFMEA and hazard analyses, integrating risk findings into design decisions and verification/validation planning.

• Define the system-level verification and validation (V&V) strategy, including test methods, acceptance criteria, sample sizes, and statistical rationale.
• Ensure V&V planning addresses all design input requirements and traces through the system architecture to corresponding test protocols and reports.
• Drive resolution of system-level nonconformances, design issues, and CAPA activities during the development lifecycle.

• Provide technical leadership to cross-functional development teams, driving evidence-based decisions with a clear understanding of total product, project, customer, and business impact.
• Mentor and coach junior and mid-level systems engineers, building organizational systems engineering capability.
• Represent Systems Engineering (SE) in program governance activities, design reviews, and regulatory strategy discussions.
• Effectively plan, coordinate, and communicate assigned SE tasks, milestones, and deliverables.
• Demonstrated Lead Practitioner–level proficiency in systems thinking, ability to define system context, predict emergent behavior, manage complexity, and adapt approaches to novel situations.
• Deep expertise in requirements engineering, including stakeholder needs analysis, requirement decomposition, and bidirectional traceability.
• Proven ability to develop and evaluate system architectures, performing functional analysis, trade studies, and design optimization.
• Extensive knowledge of medical device risk management methodologies: ISO 14971, DFMEA, Fault Tree Analysis (FTA), and Hazard Analysis.
• Working knowledge of applicable medical device standards and regulations: FDA…