Description

You will manage the full systems product lifecycle for electromechanical medical devices to ensure regulatory compliance and quality.

Responsibilities

• Translate user and business requirements into high-level product designs and technical specifications.
• Decompose and allocate derived requirements down to hardware, software, and part levels while maintaining traceability.
• Execute product safety risk management in compliance with medical device regulations.
• Lead technical and design reviews, including trade-off analyses of system specifications and interfaces.
• Optimize integration and verification processes to meet product performance and reliability targets.

Required Skills

• Systems engineering experience for electromechanical medical devices.
• Knowledge of ISO 13485, ISO 14971, and IEC 62304.
• Experience with IEC 60601-1 and other relevant medical device standards.
• Proficiency in requirements management using Jira.
• Understanding of usability and regulatory requirements for medical devices.
• Experience with product safety risk management and system decomposition.
• Master’s degree in a relevant engineering field.

Preferred Skills

• 1 year of tenure in a similar systems engineering role.

Key Skills

Education

Master’s degree