Design Transfer SME Design Controls Remediation

Role: Design Transfer SME Design Controls Remediation (Medical Device)

Duration: 12 Months

Location: Remote

Client : Medical Device

Job Summary

We are seeking a Design Transfer SME with strong medical device experience to support design transfer gap assessments and remediation activities. This role ensures smooth transition of product designs into manufacturing while maintaining compliance with design control requirements.

Key Responsibilities:

• Review and identify gaps in design transfer plans and manufacturing documentation.
• Support development and updates of Process Validations (IQ/OQ/PQ), Test Method Validations (TMV), Software Validations.
• Review and update Device Master Records (DMR) as needed.
• Ensure design transfer activities align with (V&V),Production processes,Supplier controls,Risk management requiments
• Work with cross-functional teams (Design, Manufacturing, Quality).
• Maintain traceability between Design Inputs, Outputs, and transfer documentation.

Required Qualifications :

• Bachelor's degree in Engineering or related field.
• Experience with medical device design transfer and process validation.
• Strong knowledge of ISO 13485 and 21 CFR 820 design control requirements.
• Experience supporting manufacturing process development and validation.
• Experience performing design transfer gap assessments or remediation.
• Strong documentation and coordination skills.