Principal Systems Engineer

An 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.***

• 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 activities in 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.

• B.S. or advanced degree in Engineering (Systems, Biomedical, Mechanical, or Electrical)
• 10+ years of product development engineering experience in the medical device industry
• Experience working in cross-functional teams with hardware and software engineering teams.
• 6+ years of experience in systems engineering/systems architecture development
• Strong experience translating stakeholder and technical design inputs into product and system-level requirements.
• Strong experience leading risk assessment, change control, and applying risk management methodologies, including DFMEA, FTA, and Hazard Analysis 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)