Senior Design Quality Engineer

Job Summary

To support a DHF remediation project for medical devices, the remote Senior Design Quality Engineer will review design transfer documents, ensure compliance with quality and regulatory requirements, and collaborate with cross-functional teams in a contract role.

Key responsibilities:

• Review and assess design transfer documentation for compliance
• Identify documentation gaps and support remediation activities
• Collaborate with Engineering, Quality, Manufacturing, and Regulatory teams to ensure documentation accuracy

Required qualifications:

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical discipline
• 10-15+ years of experience within the Medical Device industry
• Strong experience with Design Transfer activities in medical device development
• Demonstrated experience leading or supporting DHF remediation projects
• In-depth knowledge of FDA Design Control requirements and ISO 13485 standards