Description

You will manage systems engineering activities across the product lifecycle, from new development through post-market surveillance.

Responsibilities

• Capture requirements from standards, user needs, regulatory, quality, and manufacturing sources.
• Build and maintain Design History File elements and ensure full traceability to requirements.
• Execute risk mitigation strategies by anticipating technical challenges and conducting impact assessments for design or process changes.
• Resolve technical issues using problem-solving tools like cause and effect diagrams and Pareto charts.
• Drive consistency with FDA, ISO, and IEC design control procedures and standards.
• Mentor others in life cycle management methodologies.

Required Skills

• 3+ years of industry work experience in systems engineering.
• Bachelor's degree in Electrical, Mechanical, Biomedical, Controls, Systems, Software, or a related engineering field.
• Proven experience in electromechanical system development, specifically within medical devices or highly regulated industries like military hardware.
• Deep understanding of electro-mechanical and software engineering principles.
• Proficiency with DOORS for requirements management.
• Knowledge of FDA, ISO, and IEC design control regulations and standards.
• Strong analytical skills for solving ambiguous and diverse technical problems.
• Ability to work effectively within multi-functional, global teams.

Key Skills

Education

Bachelor's degree