Systems Engineer (medical devices)

Summary

• The Systems Engineer will support the overall technical direction of Acute Therapies products. This role involves contributing across the full product development lifecycle-from feasibility to post-market-focusing on requirements management, risk analysis, system integration, and verification/validation within a regulated medical device environment.

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
• Develop design concepts and research methodologies aligned with business and user needs
• 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
• Knowledge of requirements management and traceability
• Familiarity with risk management and reliability engineering
• Experience with connected devices / cybersecurity concepts (preferred)
• Hands-on with tools such as:
• DOORS
• Teamcenter
• TrackWise8
• JIRA / 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