Systems Engineer – Medical Devices

Swoon; Minneapolis (MN); On-site; USD 110,000 - 150,000; Full time

Job summary

Swoon seeks a Systems Engineer to support the development and lifecycle management of advanced critical-care medical devices, including systems used for renal therapies.

You will translate clinical needs into system requirements, manage design changes, and lead V&V activities across cross-functional teams to ensure regulatory compliance.

Candidate should have a 3+ year background in systems engineering within regulated environments and experience with SysML/UML, DOORS, and JAMA tools.

Qualifications

• Bachelor’s or Master’s degree in Electrical, Software, Mechanical, Biomedical Engineering or related field.
• 3+ years of systems engineering experience.
• Experience with medical devices or other regulated/safety-critical products.
• Strong experience with system requirements, risk management, integration, verification and validation.

Responsibilities

• Drive systems engineering activities from feasibility and product development through verification, validation and lifecycle management.
• Translate clinical/user needs into system requirements, design concepts and product solutions.
• Manage requirements, traceability, risk management, DHF, system integration, V&V and design changes.
• Identify technical risks, perform impact assessments and develop mitigation strategies.
• Collaborate with software, electrical, mechanical, quality, regulatory, manufacturing and clinical teams.
• Ensure compliance with FDA, ISO and IEC design-control requirements.

Skills

Systems engineering

Requirements management

Risk assessment

Cross-functional collaboration

Analytical thinking

Education

Engineering degree (Electrical/Software/Mechanical/Biomedical)

Tools

SysML/UML

DOORS

Jama

Teamcenter

TrackWise8

JIRA

ALM

Job description

We are seeking a Systems Engineer to support the development and lifecycle management of advanced critical-care medical devices, including systems used for acute kidney care and CRRT.

Key Responsibilities

• Drive systems engineering activities from feasibility and product development through verification, validation, and lifecycle management.
• Translate clinical/user needs into system requirements, design concepts, and product solutions.
• Manage requirements, traceability, risk management, DHF, system integration, V&V, and design changes.
• Identify technical risks, perform impact assessments, and develop mitigation strategies.
• Collaborate with software, electrical, mechanical, quality, regulatory, manufacturing, and clinical teams.
• Ensure compliance with FDA, ISO, and IEC design-control requirements.

Requirements

• Bachelor’s/Master’s degree in Electrical, Software, Mechanical, Biomedical Engineering, or related field.
• 3+ years of relevant systems engineering experience.
• Experience with medical devices or other regulated/safety-critical products.
• Strong experience with system requirements, risk management, integration, verification, and validation.
• Knowledge of SysML/UML and requirements management tools.
• DOORS or Jama experience preferred.
• Experience with connected/software-enabled and electro-mechanical systems preferred.
• Familiarity with Teamcenter, TrackWise8, JIRA, or ALM is a plus.
• Strong analytical, communication, problem-solving, and cross-functional collaboration skills.

Preferred Background

• Medical devices
• ICU/critical care
• dialysis/renal therapy
• CRRT
• infusion pumps
• ventilators
• patient monitoring
• or other FDA-regulated products