Principal Systems Engineer

$180,000.00 to $180,000.00Chicago United StatesPrincipal Systems EngineerAn established medical device company located in the Greater Chicago Area is hiring a Principal Systems Engineer to serve as an R&D technical lead for new product development & sustaining programs. The company develops and manufactures a portfolio of class I and class II single-use, disposable medical devices. This role will lead systems engineering activities across the full product lifecycle from concept through commercialization and sustaining efforts. The Principal Systems Engineer will work cross-functionally to lead systems-level design, requirements definition, risk management, change control, and V&V activities. This role requires strong experience leading risk assessment of product design changes from a systems-level perspective.**This is an onsite position that will require working at the office north of Chicago at least 4 days/week.***Unfortunately, this company cannot provide visa sponsorship or support OPT or H-1B transfers at this time.Role Responsibilities:Serve as technical lead for new product development programs and lead systems engineering activities across the full product life cycle.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.Provide leadership for product architecture decisions balancing performance, usability, cost, manufacturability, and regulatory requirements.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).Lead risk management activitiesin accordance with ISO 14971 throughout the product life cycle.Facilitate FMEA activities including Design FMEA, Use FMEA, and Process FMEA.Define the system-level verification and validation (V&V) strategy, including test methods, acceptance criteria, sample sizes, and statistical rationale.Work with cross-functional teams including R&D, Quality, Regulatory Affairs, Clinical Affairs, Manufacturing, Marketing, Supply Chain, and external partners to deliver innovative products.Required Experience:B.S. or advanced degree in Engineering (Systems, Biomedical, Mechanical, or Electrical)10+ years of product development engineering experience in the medical device industryexperience working in cross-functional teamswith multi-discipline design engineers.6+ years of experience in systems engineering/systems architecture developmentStrong experience translating stakeholder and technical designinputs into product and system-level requirements.Strong experience leading risk assessment, change control, and applying risk management methodologies, including DFMEA, FTA, and HazardAnalysis per ISO 14971.Experience leading design control activities across the full product development lifecycle.Experience applying model-based systems engineering (MBSE) approaches and tools (e.g., DOORS, Jama, Polarion)Ability to travel up to 25%.