Description

Own the systems engineering lifecycle for acute therapies products, specifically dialysis machines in ICU settings. Balance new product development with sustaining existing features. Apply systems thinking to translate clinical and user needs into technical requirements, design concepts, and risk mitigations.

Responsibilities

• Capture and trace requirements from user needs, regulatory standards, and cross-functional inputs.
• Create and maintain design history file elements and system modeling documentation.
• Drive design realization by resolving complex technical issues using cause-and-effect diagrams and Pareto charts.
• Conduct impact assessments for design, material, or process changes and propose mitigations.
• Facilitate understanding of interrelationships between requirements, risk, and reliability.

Required Skills

• 8+ years of experience in systems engineering, preferably in medical devices or regulated industries (aerospace, automotive, military).
• Strong background in electro-mechanical system development and embedded software.
• Proficiency in System Modeling Language (SysML or UML) and requirement management.
• Experience with Internet-connected, software-enabled devices and cybersecurity principles.
• Knowledge of FDA, ISO, and IEC design control procedures and regulations.
• Ability to work independently and manage multiple projects with shifting priorities.
• Strong analytical, problem-solving, and communication skills for influencing stakeholders.

Preferred Skills

• Working knowledge of DOORS, Teamcenter, TrackWise, JIRA, and ALM tools.
• Familiarity with statistical methods for design and verification, such as DOE and sample size calculation.
• Experience in the ICU or kidney care domains.

Key Skills

Education

Bachelor's or Master's degrees