Design Controls Remediation Engineer

United Consulting Hub is seeking professionals with experience in Hardware, Embedded Software, Cybersecurity, Systems, Software, Clinical, or Quality Engineering to support Design Controls Remediation projects within regulated medical device environments. The role involves reviewing and updating documentation, supporting remediation activities for FDA and ISO compliance, and collaborating with various teams to maintain audit readiness.

Responsibilities:

• Review and update DHF, requirements, risk, verification, and validation documents
• Support remediation activities for FDA and ISO compliance
• Perform gap assessments and documentation updates
• Collaborate with Quality, Regulatory, R&D, and Clinical teams
• Maintain traceability and support audit readiness activities

Requirements:

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field
• Experience in medical devices or regulated industries
• Knowledge of FDA Design Controls, ISO 13485, IEC 62304, and Risk Management
• Strong documentation and communication skills
• Experience with remediation, validation, or compliance projects
• Familiarity with tools such as Jira, DOORS, Polarion, or Jama