Medical Device Systems Engineer – V&V & DHF

Novozen Healthcare LLC; Minnesota; Vor Ort; USD 52.000 - 54.000; Teilzeit

Zusammenfassung

Novozen Healthcare LLC in Plymouth, Minnesota seeks a Systems Engineer to support medical devices across development and lifecycle stages. The role emphasizes translating user needs into system requirements, maintaining traceability, and ensuring V&V and DHF compliance.

The ideal candidate has 3+ years in a regulated environment, strong electromechanical/software systems knowledge, and familiarity with requirements management, risk management, and design controls in a healthcare setting.

Qualifikationen

• Bachelor's or Master's degree in Electrical, Software, Mechanical, Biomedical Engineering, or a related field.
• Minimum 3 years of relevant engineering experience.
• Strong systems engineering background involving electromechanical and software-based systems.
• Experience with regulated medical devices or other highly regulated products (e.g., aerospace, automotive, or military).
• Experience with requirements management, risk management, system integration, verification, and validation (V&V).
• Knowledge of connected and software-enabled devices and cybersecurity is preferred.
• Familiarity with SysML/UML and requirements management tools.

Aufgaben

• 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 design concepts and system architectures, 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 effective mitigation strategies.
• Collaborate cross-functionally with Software, Electrical, Mechanical, Quality, Regulatory, Manufacturing, and Service teams.
• Ensure compliance with FDA regulations, ISO and IEC standards, and medical device design control requirements.

Ausbildung

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

Jobbeschreibung

Novozen Healthcare LLC in Plymouth, Minnesota seeks a Systems Engineer to support medical devices across development and lifecycle stages. The role emphasizes translating user needs into system requirements, maintaining traceability, and ensuring V&V and DHF compliance.

The ideal candidate has 3+ years in a regulated environment, strong electromechanical/software systems knowledge, and familiarity with requirements management, risk management, and design controls in a healthcare setting.