Senior Manufacturing Process 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:

  • Support prototype and pilot production of new products, product changes, and enhancements in coordination with Process and Quality Control functions
  • Support various process validation activities (e.g., development and execution of IQ/OQ/PQ)
  • Develop work instructions, workmanship standards and process documents, and ensure they are followed
  • Determine design approaches and parameters and analyze mechanical systems, equipment, and packaging etc
  • Continuous improvement of existing development and manufacturing operations for increased quality, productivity, efficiency, and cost savings
  • Investigate and report on production issues. Propose and implement solutions
  • Manage manufacturing documentation required for product manufacturing (e.g., 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
  • Actively participate in concept development for new or existing products
  • Create and execute design V&V protocols
  • Support design-related documentation creation and revision for design history file
  • Provide a leading role and for development and manufacturing processes and equipment. Identify alternative suppliers as needed
  • Research, design, and develop processes to optimize productivity and workflow
  • Train and supervise staff on processes and technology
  • Ensure appropriate process documentation and validation to lead manufacturing transfer and scale-up
  • Train technicians and assemblers
  • Other duties as required

EXPERIENCE/ SKILL REQUIREMENTS:

Minimum of 5 years of 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
  • Mechanical Design
  • Developing catheters or similar products
  • Hands on manufacturing experience
  • Team player with solid communication skills

EDUCATIONAL REQUIREMENTS:

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