About this role
Role: Design Transfer Workstream Manager DHF Remediation
Location: Remote
Duration: Long Term
Role Summary
The Design Transfer Workstream Lead will lead the retrospective review of design transfer documentation to ensure the design was appropriately transferred to manufacturing. This role will support assessment of documentation supporting manufacturing readiness and product realization.
Responsibilities
- Lead the retrospective review of design transfer documentation.
- Assess documentation supporting transfer of the design to manufacturing.
- Evaluate manufacturing specifications, procedures, and supporting documentation associated with transfer.
- Identify gaps in documentation supporting design transfer activities.
- Coordinate with the Outputs, Verification, and Validation workstream leads to ensure alignment between design documentation and manufacturing documentation.
- Support development of remediation strategies where transfer documentation gaps are identified.
Qualifications
- Experience supporting design transfer within medical device development.
- Experience participating in remediation initiatives involving manufacturing or design transfer documentation.
- Familiarity with product realization and manufacturing documentation requirements.
- Experience working with engineering, quality, and manufacturing teams.
- Experience with complex software systems
- Has led a design transfer medical device remediation effort
- Experience with integrated software and test method validation