Systems Engineer (medical devices)

Roles & Responsibilities

• Support systems engineering activities across all product lifecycle stages (NPD to post-market)
• Translate clinical and user needs into product requirements
• Gather and manage requirements from cross-functional inputs (regulatory, quality, manufacturing, service, etc.)
• Drive system-level design and product realization using engineering best practices
• Create and maintain Design History File (DHF) documentation
• Ensure traceability between requirements, risks, and verification activities
• Identify technical risks early and implement mitigation strategies
• Perform system integration, verification, and validation activities
• Conduct root cause analysis using tools like fishbone diagrams, Pareto charts, etc.
• Assess impact of design/process/material changes and recommend solutions
• Collaborate and influence cross-functional teams and stakeholders
• Ensure compliance with FDA, ISO, and IEC design control standards
• Utilize tools/software to support engineering and documentation activities

Required Skills & Qualifications

• Strong understanding of systems engineering principles
• Experience with electro-mechanical and/or software-integrated systems
• Familiarity with requirements management and traceability
• Experience with risk management and reliability engineering
• Experience with connected devices / cybersecurity concepts (preferred)
• Hands-on with tools such as: DOORS, Teamcenter, TrackWise, 8JIRA / ALM
• Working knowledge of SysML or UML
• Understanding of statistical methods (DOE, sampling, etc.)
• Strong analytical, problem-solving, and communication skills
• Ability to work independently and manage multiple priorities
• Experience in medical devices, especially ICU or kidney care products
• Background in regulated industries (medical, aerospace, automotive, military)
• Experience working with global, cross-functional teams
• Bachelor's or Master's degree in: Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Software Engineering (or related field)
• 3+ years of relevant experience