Medical Device domain for a Design Controls.

Location: Remote

Duration: Contract

Open Positions:

• Software Engineer – Design Controls Remediation
• Hardware Engineer – Design Controls Remediation
• Embedded Software Engineer
• Cyber Security Engineer
• Validation SME

Job Responsibilities:

• Perform gap assessments across Design Inputs, Outputs, V&V, and Risk Management
• Drive remediation activities to meet regulatory standards
• Work closely with cross-functional engineering teams
• Ensure compliance with FDA, ISO, and IEC standards

Required Skills:

• Strong experience in Medical Device industry
• Hands-on experience in Design Controls & Remediation
• Knowledge of standards like IEC 62304, ISO 13485, FDA 21 CFR 820
• Domain expertise in respective areas (Software / Hardware / Embedded / Cybersecurity / Validation)