Location: 
Sudbury
Employment Type: 
Permanent
Job ID: 
134510
Description: 

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.

EXPERIENCE/SKILL REQUIREMENTS:  

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.

EDUCATIONAL REQUIREMENTS: 

  • Bachelor’s Degree in a technical field (or equivalent job experience).

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