Design Controls Remediation Engineer

Job Title: Design Controls Remediation Engineer Location: United States (Remote) Employment Type: Contract Job Summary: We are 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. 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 Qualifications: • 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 Preferred: • Experience with remediation, validation, or compliance projects • Familiarity with tools such as Jira, DOORS, Polarion, or Jama Apply / Refer: Abhiram Recruiter | United Consulting Hub Email: abhiram@unitedconsultinghub.com