Manufacturing

Development and optimization of production methods for device manufacture
Development of strategy and approach to streamline manufacturing efforts
Composing and reviewing manufacturing documents, including:
- Test protocols and reports
- SOPs, batch records, and related GMP documents
- Process Flowcharts
Risk assessments and gap analysis of manufacturing process
Tolerance/Specification development
Technical investigation of failures and rejects
Hands-on assistance during manufacturing start-up (person in plant)
Master planning, scheduling and tracking of manufacturing efforts
Assistance with Facility design
Writing and review of documents for global regulatory submissions
Planning and performing equipment calibrations
Long-term planning and process feasibility (Project Management)