Embedded Software Engineer-Medical Device domain
Posted 3 days ago by Gurus Infotech, Inc.
Negotiable
Undetermined
Remote
Remote
Summary: The Embedded Software Engineer role focuses on ensuring compliance with design controls in the medical device domain. The position involves conducting gap assessments and driving remediation activities to meet regulatory standards. The engineer will collaborate with cross-functional teams to ensure adherence to FDA, ISO, and IEC standards. This is a contract position with remote working arrangements.
Key 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
Key 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)
Salary (Rate): undetermined
City: undetermined
Country: undetermined
Working Arrangements: remote
IR35 Status: undetermined
Seniority Level: undetermined
Industry: IT
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)