Description

Define clinical, functional, and technical requirements for medical device algorithms and instrumentation while ensuring FDA compliance.

This role is on-site.

Responsibilities

• Translate input requirements into specific system requirements and interface specifications.
• Execute system-level testing and create comprehensive System Testing Plans.
• Conduct feasibility studies, technology assessments, and benchmarking through cross-functional collaboration.
• Resolve technical issues and ensure compliance with FDA regulations and Quality Management Systems (QMS).

Required Skills

• 5+ years of experience in system engineering roles.
• Hands-on experience with DOORS for system software testing.
• Direct experience working within Medical Device Standards.
• Working knowledge of Quality Management Systems (QMS).
• Ability to translate complex clinical and functional requirements into technical specifications.
• Experience navigating FDA regulations and regulatory requirements.

Preferred Skills

• Experience with electromechanical hardware and device testing.
• Background in Cardiac Management device testing.

Key Skills

Education

Any Graduate