Senior Medical Devices Systems Engineer – ICU CRRT

The Carrera Agency; Minneapolis, Saint Paul (MN, MN); On-site; USD 123,984,000 - 151,536,000; Full time

Job summary

The Carrera Agency is seeking a Systems Engineer to support acute therapy medical products in a 1-year contract. You will lead feasibility through lifecycle management, including design concept, requirements management, DHF maintenance, and risk management for ICU CRRT devices. This role emphasizes cross-functional collaboration and regulatory compliance.

Join a team advancing connected medical systems with attention to patient safety and device reliability in high-stakes environments.

Qualifications

• Bachelor's or Master's in Electrical, Software, Mechanical, Biomedical or related field.
• 3+ years of relevant experience in medical devices or regulated industries.
• Experience in electro-mechanical system development and design controls.
• Familiarity with FDA/ISO/IEC design control practices.

Responsibilities

• Perform systems engineering across products from development to post-market.
• Capture requirements from user needs, regulatory and quality inputs.
• Develop DHF elements and maintain design history files.
• Drive risk management, system integration and verification/validation activities.
• Ensure compliance with design control procedures and standards.

Skills

Systems engineering

Medical devices

Requirements management

Regulatory compliance

Risk management

System integration

Verification & validation

Education

Bachelors/Masters in engineering

Tools

DOORS

Jama

SysML/UML

JIRA

ALM

Teamcenter

TrackWise8

Job description

The Carrera Agency is seeking a Systems Engineer to support acute therapy medical products in a 1-year contract. You will lead feasibility through lifecycle management, including design concept, requirements management, DHF maintenance, and risk management for ICU CRRT devices. This role emphasizes cross-functional collaboration and regulatory compliance.

Join a team advancing connected medical systems with attention to patient safety and device reliability in high-stakes environments.