Description

Own the systems engineering lifecycle for acute therapies products, specifically dialysis machines in ICU settings.

This role is on-site.

Responsibilities

• Translate clinical and user needs into technical requirements, design concepts, and risk mitigations.
• 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.
• 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.
• 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.

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.

Key Skills

Education

Bachelor's or Master's degrees