Principal System Engineer

Summary

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.

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; - M.S. in Engineering (Systems, Biomedical, Mechanical, Electrical, or Software Engineering) with 8+ years of relevant experience; - 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.