Description

You will drive technical direction and product development from feasibility through lifecycle management for novel products.

Responsibilities

• Lead systems engineering activities across the product lifecycle, including new product development and post-market surveillance.
• Capture and manage requirements from standards, user needs, regulatory, quality, human factors, and manufacturing sources.
• Build and maintain Design History File elements while ensuring full traceability to requirements.
• Mitigate technical risks by anticipating challenges and executing mitigation strategies.
• Resolve ambiguous technical issues using problem-solving tools like cause and effect diagrams and Pareto charts.
• Ensure compliance with FDA, ISO, and IEC design control procedures and standards.
• Mentor technical staff in lifecycle management methodologies.

Required Skills

• 8+ years of industry experience in systems engineering.
• Proven track record in electromechanical system development, specifically within medical devices or highly regulated industries like military hardware.
• Sound knowledge of electro-mechanical and software engineering.
• Expertise in Systems Engineering, FDA, ISO, and IEC standards.
• Proficiency with requirements management tools such as DOORS.
• Ability to perform impact assessments on design, material, or process changes.
• Strong analytical and problem-solving skills.
• Experience working with multi-functional, global teams.
• Bachelor's degree in Electrical, Mechanical, Biomedical, Controls, Systems, Software, or a related engineering field.

Key Skills

Education

Any Gradute