Manufacturing Development Engineer

Our Company

Gentuity is an exciting and highly innovative medical technology firm, active in the research and development, clinical translation, and commercialization of vascular imaging devices.  This opportunity provides the candidates the unique chance to work on innovative medical products, with the potential to significantly change the practice of medicine in the care of patients suffering from a wide range of highly debilitating vascular diseases.

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.
  • Train and supervise staff on processes and technology.
  • Establish and maintain a training and quality culture.

Other duties as required

EXPERIENCE/SKILL REQUIREMENTS:   

Minimum of five (3-5) years’ experience in medical device development or other 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.
  • Hands on manufacturing experience
  • Team player with solid communication skills

EDUCATIONAL REQUIREMENTS:  

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