Hardware Engineer Medical Device domain

Summary: The Hardware Engineer role focuses on the Medical Device domain, specifically in Design Controls. The position involves conducting gap assessments, driving remediation activities, and ensuring compliance with regulatory standards. This is a contract position that allows for remote work. The ideal candidate will have strong experience in the medical device industry and relevant design controls expertise.

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: Other