Principal System Engineer

We Make Life More Rewarding and Dignified 

Location: ​Libertyville​
Department: ​Research & Development 

Principal Systems Engineer

Summary

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.

Responsibilities

Requirements Engineering & Stakeholder Management

• 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.

System Architecture & Design

• 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.

Risk Management

• 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.

Verification & Validation

• 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.

Technical Leadership & Cross-Functional Collaboration

• 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.

Essential Competencies

Technical Competencies

• 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 21 CFR 820, ISO 13485, and IEC 62366-1 (usability).
• Experience with system modeling and analysis tools and methods, including proficiency in MBSE concepts and at least one requirements management platform.

Professional & Leadership Competencies

• Strong technical leadership with the ability to influence without direct authority across engineering, quality, regulatory, manufacturing, and clinical stakeholders.
• Excellent communication skills: ability to clearly articulate complex technical concepts to both technical and non-technical audiences.
• Demonstrated ability to coach and mentor developing engineers in systems engineering principles and practices.
• Effective negotiation and facilitation skills for resolving conflicting requirements, priorities, and resource constraints across teams.
• Proactive decision-making grounded in critical thinking, data analysis, and sound engineering judgment.
• Ability to rapidly understand project trade-offs, interdependencies, and constraints, and drive day-to-day decisions to ensure robust, compliant products.

Work Experience Requirements

• 10+ years of engineering experience in regulated product development, with a minimum of 8 years in the medical device industry.
• 8+ years of experience working in cross-functional teams consisting of discipline-specific design engineers.
• 6+ years of experience translating stakeholder and technical design input requirements using systems engineering principles to develop system architectures and specifications with clear boundary conditions.
• 6+ years of experience applying risk management methodologies, including DFMEA, FTA, and Hazard Analysis per ISO 14971.
• Demonstrated experience leading design control activities across the full product development lifecycle (concept, feasibility, design, verification, validation, and design transfer).

Education Requirements

• B.S. in Engineering (Systems, Biomedical, Mechanical, Electrical, or Software Engineering) with 12+ years of relevant experience; or
• M.S. in Engineering (Systems, Biomedical, Mechanical, Electrical, or Software Engineering) with 10+ years of relevant experience; or
• Ph.D. in a relevant engineering discipline with 8+ years of relevant experience.

Preferred Certifications

• INCOSE Certified Systems Engineering Professional (CSEP) or Expert Systems Engineering Professional (ESEP).
• ISO 13485 Lead Auditor certification.
• Certification or formal training in ISO 14971 Risk Management.

Physical Requirements

• Primarily office and laboratory setting; ability to perform and/or oversee laboratory testing and use standard lab equipment as required by the program.
• Ability to work at a computer for extended periods and to collaborate in meetings across sites and time zones.
• Occasional handling of materials, packaging/equipment components, and samples; use of appropriate personal protective equipment (PPE) per site procedures.

Travel Requirements

Travel up to approximately 25%, with occasional increases depending on project phase and support for manufacturing, suppliers, testing labs, clinical sites, or industry events.

Our Total Rewards package in aggregate is above market and includes competitive pay, paid time off programs, peer-to-peer recognition, health and life insurance, wellness programs and incentives, and generous retirement savings.

• The anticipated base pay range for this position is $140,000 - $191,000 yearly. The actual salary varies based on applicant's location, education, experience, skills, abilities, and other legitimate business factors.​
• This position is also eligible to participate in the Hollister Corporate Bonus Plan.
• The Company’s health and welfare benefits include medical, prescription, dental, vision, spending/savings accounts, disability, company paid (parental and caregiver) leaves, statutory leaves/disability programs, accident, life, wellbeing, education assistance, adoption assistance, and voluntary benefit programs. ​
• The Company’s 401(k) Retirement Savings Plan includes: auto-enrollment, ROTH, vesting and eligible participants “safe harbor” matching contributions. ​
• The Company’s paid time off benefits include: 11 paid holidays, paid vacation based on length of service and exempt/non-exempt status, and sick days based on statutory requirements and/or exempt/non-exempt status. ​
• The Company’s additional benefits include: education assistance and adoption assistance benefit programs. 

About Hollister Incorporated
Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.

EOE Statement
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job Req ID: 35800