Principal System Engineer

Principal System Engineer

The Principal Systems Engineer serves as the technical leader responsible for systems-level design, integration, and lifecycle management of single-use disposable medical products. This role drives product architecture, requirements definition, risk management, and technical decision-making throughout product development, ensuring safe, effective, manufacturable, and compliant products. The Principal Systems Engineer collaborates closely with cross-functional teams including R&D, Quality, Regulatory Affairs, Clinical Affairs, Manufacturing, Marketing, Supply Chain, and external partners to deliver innovative products that meet customer and business objectives.

Systems Engineering Leadership: Lead systems engineering activities across the full product lifecycle from concept through commercialization and sustaining efforts. Develop and maintain system architecture, product requirements, and technical specifications for single-use disposable medical products. Translate customer, clinical, regulatory, and business needs into system-level requirements. Establish traceability between user needs, design inputs, verification activities, and design outputs. Drive decomposition of system requirements into subsystem and component-level requirements.

Product Development & Technical Leadership: Serve as technical lead for new product development programs involving single use disposable medical devices. Provide leadership for product architecture decisions balancing performance, usability, cost, manufacturability, and regulatory requirements. Identify and resolve complex technical challenges requiring multidisciplinary solutions. Lead technical reviews and design decisions throughout development phases.

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.

Risk Management & Compliance: Lead risk management activities in accordance with ISO 14971 throughout the product lifecycle. Facilitate FMEA activities including Design FMEA, Use FMEA, and Process FMEA. Ensure products comply with applicable standards and regulations including: FDA Quality System Regulation / Quality Management System requirements EU Medical Device Regulation (MDR) ISO 13485 IEC 62366 (Usability Engineering) Applicable biocompatibility and sterilization standards Support preparation of regulatory submissions and technical documentation.

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. Support design verification, human factors studies, and clinical evaluations as required. Analyze technical data and identify opportunities for product and process improvements.

Cross-Functional Collaboration: Partner with Manufacturing Engineering to ensure robust design transfer and scalable production processes. Support post-market surveillance, complaint investigations, and continuous improvement initiatives. Interface with customers and clinical stakeholders to understand unmet needs and emerging technologies.

Essential Competencies: Systems thinking, technical leadership, strategic decision-making, cross-functional collaboration, risk assessment and mitigation, product lifecycle management, customer focus, communication and influence, problem solving.

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 10+ years of relevant experience; or M.S. in Engineering (Systems, Biomedical, Mechanical, Electrical, or Software Engineering) with 8+ years of relevant experience; or Ph.D. in a relevant engineering discipline with 5+ years of relevant experience.

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