We are seeking a highly detail-oriented and collaborative Sr. Manufacturing Engineer to support manufacturing and regulatory initiatives related to product transitions, labeling compliance, and variant management. This role serves as a subject matter expert on manufacturing process information and labeling documentation for externally manufactured medical products, with a focus on compliance with company address changes and regulatory standards.
Key Responsibilities:
Collaborate with Regulatory Affairs and Supply Chain to support product transitions related to LM (Legal Manufacturer) address changes.
Compile and consolidate manufacturing information per product family in coordination with cross-functional teams including Quality, R&D, Engineering, and Suppliers.
Maintain live documentation to ensure continued compliance with LM address requirements.
Act as the Subject Matter Expert (SME) for manufacturing process data across multiple product lines at a manufacturing site.
Manage and oversee documentation and compliance for Externally Manufactured (EM) products owned by the company.
Conduct gap assessments for patient-facing materials such as Labels, Instructions for Use (IFU), Implant Cards, and Patient Information Leaflets (PIL).
Drive the implementation of multi-variant product changes.
Update Bills of Materials (BOM) and Device Master Records (DMR) to reflect variant code changes tied to LM address updates.
Support assessments for manufacturing impacts from new variant introductions.
Lead and coordinate variant introduction activities with support from broader engineering teams.
Create label redlines and generate Labeling Request Forms (LRFs) following new LM address standards.
Act as the PLM (Product Lifecycle Management) expert and change order owner for labeling updates across JDE, Windchill, and Adaptiv systems.
Provide daily status updates and progress reports on deliverables in cross-functional meetings.

Please refer the Job description for details