Description

You will lead the systems engineering lifecycle for CGM wearable devices, from requirement elicitation to verification and validation.

Responsibilities

• Elicit, analyze, and document hardware requirements for CGM wearables, including patch overlay design, mechanical robustness, and sensor accuracy.
• Develop hardware architecture diagrams, interface specifications, and system-level design documents.
• Collaborate with mechanical, electrical, firmware, and test engineering teams to integrate hardware components and subsystems.
• Conduct FMEA risk assessments to identify and mitigate hardware-related risks.
• Define test cases and analyze results to support verification and validation activities.
• Maintain hardware requirements, design decisions, and risk assessments within Jama Connect.

Required Skills

• 5+ years of experience in hardware systems engineering.
• 2+ years of experience specifically focused on wearable medical devices.
• Proven experience authoring and managing hardware requirements using Jama Connect.
• Deep understanding of wearable hardware design, including patch overlay, sensor integration, and miniaturization.
• Experience with risk management processes such as FMEA applied to medical device development.
• Knowledge of mechanical design, electrical component selection, and reliability testing.
• Ability to manage hardware architecture and interface specifications.
• B.S. in Electrical, Mechanical, or Biomedical Engineering, or a related field.

Preferred Skills

• Experience with CGM technology or other medical device development.
• Skills in statistical analysis and data interpretation.
• Familiarity with ISO 13485 and relevant regulatory standards.

Key Skills

Education

Any Graduate