System Engineer

Fusion Life Sciences Technologies LLC; Plymouth (MN); On-site; USD 110,000 - 140,000; Full time

Job summary

Fusion Life Sciences Technologies LLC is seeking a dedicated Systems Engineer to shape medical device development across new products, sustaining engineering, and post-market support.

You will translate clinical needs and regulatory requirements into precise system specifications, manage risk and design controls, and collaborate across software, electrical, mechanical, quality, regulatory, and manufacturing teams to ensure patient safety and regulatory compliance.

Qualifications

• Bachelor’s or Master’s degree in a relevant engineering field.
• 3+ years of systems engineering experience in medical devices or regulated products.
• Experience with requirements management, risk management, design controls, and electro-mechanical systems.
• Knowledge of SysML/UML and requirements tools such as DOORS or Jama.
• Experience with connected/software-enabled devices or cybersecurity is a plus.
• Strong analytical, problem-solving, communication, and stakeholder-management skills.
• Preferred tools: Teamcenter, TrackWise 8, JIRA, and ALM.

Responsibilities

• Support systems engineering activities across new product development, sustaining engineering, and post-market activities.
• Translate clinical/user needs and regulatory requirements into system requirements and specifications.
• Develop and maintain system requirements, traceability, risk management, and DHF documentation.
• Support electro-mechanical and software-enabled medical device development, integration, verification, and validation.
• Identify technical risks, perform impact assessments, and lead risk mitigation and root-cause activities.
• Troubleshoot complex system-level issues using structured problem-solving tools.
• Collaborate with Software, Electrical, Mechanical, Quality, Regulatory, Manufacturing, and Human Factors teams.
• Ensure compliance with FDA, ISO, IEC, and design control requirements.
• Manage multiple projects, priorities, and technical deliverables in a cross-functional environment.

Skills

Systems engineering

Requirements management

Risk management

Cross-functional collaboration

Analytical problem solving

Regulatory compliance

Stakeholder management

Education

Bachelor’s/Master’s degree in Electrical, Software, Mechanical, Biomedical Engineering, or related field

Tools

DOORS

Jama

SysML/UML

Teamcenter

TrackWise 8

JIRA

ALM

Job description

• Support systems engineering activities across new product development, sustaining engineering, and post-market activities.
• Translate clinical/user needs and regulatory requirements into system requirements and specifications.
• Develop and maintain system requirements, traceability, risk management, and DHF documentation.
• Support electro-mechanical and software-enabled medical device development, integration, verification, and validation.
• Identify technical risks, perform impact assessments, and lead risk mitigation and root-cause activities.
• Troubleshoot complex system-level issues using structured problem-solving tools.
• Collaborate with Software, Electrical, Mechanical, Quality, Regulatory, Manufacturing, and Human Factors teams.
• Ensure compliance with FDA, ISO, IEC, and design control requirements.
• Manage multiple projects, priorities, and technical deliverables in a cross-functional environment.

Required Qualifications

• Bachelor’s/Master’s degree in Electrical, Software, Mechanical, Biomedical Engineering, or related field.
• 3+ years of relevant systems engineering experience, preferably in medical devices or regulated products.
• Experience with requirements management, risk management, design controls, and electro-mechanical systems.
• Knowledge of SysML/UML and requirements tools such as DOORS or Jama.
• Experience with connected/software-enabled devices or cybersecurity is a plus.
• Strong analytical, problem-solving, communication, and stakeholder-management skills.
• Preferred tools: Teamcenter, TrackWise 8, JIRA, and ALM.