Description

Drive technical direction and product development from feasibility through lifecycle management for novel electromechanical products.

This role is hybrid.

Responsibilities

• Lead systems engineering activities across the full product lifecycle, including new product development and post-market surveillance.
• Capture and manage requirements from standards, user needs, regulatory bodies, 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.

Required Skills

• 8+ years of industry experience in systems engineering.
• Proven track record in electromechanical system development within medical devices or highly regulated industries like military hardware.
• Sound knowledge of electro-mechanical and software engineering principles.
• 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.

Preferred Skills

• Bachelor's degree in Electrical, Mechanical, Biomedical, Controls, Systems, Software, or a related engineering field.
• Experience mentoring technical staff in lifecycle management methodologies.

Key Skills

Education

Any Gradute