Medical Device Systems Engineer - V&V & Regulatory

Novozen Healthcare LLC; Plymouth (MN); On-site; USD 48,000 - 54,000; Full time

Job summary

Novozen Healthcare LLC is seeking a systems engineer to translate clinical needs into robust system requirements and maintain traceability across the product lifecycle. You will develop architectures, support system integration, and drive verification and validation activities for regulated medical devices.

The role requires strong analysis, experience with design controls, and collaboration with software, hardware, QA, regulatory, and manufacturing teams.

Qualifications

• Bachelor's or Master's degree in Electrical, Software, Mechanical, Biomedical Engineering, or a related field.
• 3+ years of relevant engineering experience.
• Strong systems engineering background involving electro-mechanical and software-based systems.
• Experience developing medical devices or other highly regulated products, such as aerospace, automotive, or military systems.
• Experience with requirements management, risk management, system integration, and V&V.
• Knowledge of SysML/UML and requirements management tools.
• Strong analytical, problem-solving, communication, and stakeholder-management skills.

Responsibilities

• Support systems engineering activities across new product development and product lifecycle management.
• Translate clinical and user needs into system requirements and maintain requirements traceability.
• Develop system concepts and architecture, and support system integration, verification, and validation (V&V).
• Maintain Design History Files (DHF) and product risk-management documentation.
• Conduct impact assessments for design, material, process, manufacturing, and field changes.
• Identify technical risks, troubleshoot system issues, and develop mitigation strategies.
• Collaborate with Software, Electrical, Mechanical, Quality, Regulatory, Manufacturing, and Service teams.
• Ensure compliance with FDA, ISO, IEC, and medical device design control requirements.

Skills

Systems engineering

Requirements management

V&V (verification & validation)

Risk management

Stakeholder communication

Analytical problem solving

Education

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

Tools

DOORS

Jama

Teamcenter

TrackWise 8

JIRA

ALM

Job description

Novozen Healthcare LLC is seeking a systems engineer to translate clinical needs into robust system requirements and maintain traceability across the product lifecycle. You will develop architectures, support system integration, and drive verification and validation activities for regulated medical devices.

The role requires strong analysis, experience with design controls, and collaboration with software, hardware, QA, regulatory, and manufacturing teams.