Associate 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:

  • Concurrent Engineering: Support new product development or existing product line extension/modification by ensuring new products or manufacturing processes are design to facilitate ease of manufacturing and to produce qualify, cost effective products with optimize yields.
  • Product Support and Trouble Shooting: Provide engineering support to manufacturing operation on routine basis. Address product related issues arising on the production floor…
  • Define and Generate all Required Documentation in Support of Manufacturing Product and Processes: These include engineering protocols, FMEA’s, reports, CAPA’s, manufacturing instructions and procedures. Ensure compliance with GMP’s and internal protocols.
  • Determine specific requirements of manufacturing operation in order to specify equipment, fixturing and processes parameters. Collaborate on design with suppliers to fulfill equipment and fixturing requirements.
  • Continually improve manufacturing methods/systems and process/product improvements to optimize product performance and reduce manufacturing costs.
  • Qualification and Validation: Develop plans to evaluate process repeatability and stability through equipment qualification and process validation. Applies six sigma methodologies as appropriate. This job description is not all inclusive. Incumbents may be required to complete other miscellaneous responsibilities as required.
  • Support packaging and sterilization validation
  • Train technicians and assemblers as needed
  • Other duties as assigned by manager

EXPERIENCE/SKILL REQUIREMENTS: 

Minimum of two (2-3) 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 in MS Word, Excel, Powerpoint and Project.
  • Knowledge of SolidWorks
  • Good communication and interpersonal skills (written and verbal)
  • Medical device processing experience preferred
  • FDA Quality System Regulation and/or ISO 13485 requirements for the design of medical devices.
  • Hands on manufacturing experience
  • Team player with solid communication skills

EDUCATIONAL REQUIREMENTS:

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