Hardware Engineer – Design Controls Remediation

United Consulting Hub is seeking an experienced Hardware Engineer – Design Controls Remediation to support remediation and compliance activities within a regulated medical device environment. The ideal candidate will have strong experience with design controls, hardware engineering documentation, remediation projects, and regulatory compliance while supporting cross-functional engineering and quality teams.

Responsibilities:

• Support design controls remediation activities for medical device hardware products
• Review and update design documentation to ensure compliance with FDA and regulatory requirements
• Support remediation of:
• Design History Files (DHF)
• Risk Management Documentation
• Verification & Validation Records
• Engineering Change Documentation
• Collaborate with Quality, Regulatory, R&D, and Manufacturing teams
• Perform gap assessments and support corrective actions for design control compliance
• Support hardware product development and lifecycle documentation activities
• Ensure documentation aligns with FDA, ISO 13485, and internal quality standards
• Maintain accurate and audit-ready engineering records

Requirements:

• Bachelor's degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or related field
• Strong experience in hardware engineering within the medical device industry
• Hands-on experience with: Design Controls, Design Remediation, DHF Remediation, Risk Management, Verification & Validation Documentation
• Strong understanding of FDA regulations and ISO 13485 requirements
• Excellent technical writing and documentation skills
• Ability to work independently in a remote environment
• Experience supporting remediation or compliance projects
• Familiarity with CAPA, change control, and quality systems
• Experience with electromechanical or embedded medical devices
• Knowledge of IEC standards and regulatory submission support