Negotiable
Undetermined
Remote
Remote
Embedded Software Engineer-Medical Device domain for a Design Controls.
Location: Remote
Duration: Contract
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)