SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:
- Organize, implement and maintain production flows.
- Develop work instructions, workmanship standards and process documents, and ensure they are followed.
- Continuous Improvement of existing operations for increased quality, productivity, efficiency and cost savings.
- Investigate and report on production issues. Propose and implement solutions.
- Liaise with production planner/scheduler for ensuring the released products have adequate BOM and routings.
- Manage manufacturing documentation required for product manufacturing (i.e. revise drawing, BOM, work instructions and workmanship standards and process procedures.
- Generate and report on manufacturing metrics in the form of production control charts, reliability, process capability, histogram, pareto to improve, monitor and measure progress.
- Develop process FMEAs.
- Develop and run protocols including IQ, OQ, PQ activities as required.
- Work with other relevant departments to determine estimated costs, run time, and close the feedback loop.
- Identify and propose ways to reduce production costs and improve manufacturability (i.e. new process equipment).
- Manage product scale-up from R&D to production and oversee potential product transfer.
- Support in the sourcing and approval of suppliers for manufacturing processes and equipment. Identify alternative suppliers as needed.
- Analyze and plan work force utilization, space requirements, and workflow. Design layout of equipment and workspace for maximum efficiency. Investigate and troubleshoot issues that arise with new layouts and operations.
- Research, design, and develop processes to optimize productivity and workflow.
- Clearly communicate ideas and findings to management and colleagues.
Three plus years’ experience in regulated industry.
- Experience with FDA’s Medical Device Regulations and ISO 13485
- Knowledge of Quality Systems
- Knowledge of SolidWorks
- Experience working in a startup environment a plus.
- Experience with fiber optic components and processing a plus.
- Bachelor’s Degree in a technical field (or equivalent job experience).