Manufacturing Engineer

Franklin Lakes, New Jersey | Engineering

Manufacturing Engineer 

 

This is a rare opportunity with a dynamic med device start-up involved in a very novel technology that addresses an unmet clinical need.  The bonus here is that this is a group of people who have successfully introduced other new products to med device so their knowledge of what it takes to achieve results is unmatched. 

 

The individual must have a 4 year degree in engineering, Chemical preferred, and a minimum of 2 years’ experience in Medical Device manufacturing.  Other critical experience includes Continuous Improvement Projects, Test Method Validation, Equipment/Process Validation and CAD experience with SolidWorks. 

 

You will work cross-functionally to ensure documentation is compliant to the needs of ISO 13485, 21 CFR 820, and FDA regulations; participating in Risk Analysis, Data Collection/Analysis, Controls & Procedures.  Still interested?  Read on. 

 

RESPONSIBILITIES: (The first three are must haves)

  • Test Method Validation ensuring proper definition of devices (e.g. Refractometers, Gas Chromatography) to provide for accurate gauging and inspection resulting in reliable and repetitive results
  • Hands-on responsibility for IQ/OQ/PQ and the documentation needed during those steps, e.g. DOE, FMEA
  • Devise a program to evaluate the precision and accuracy of equipment
  • Lean/Six Sigma knowledge applied to process improvement across a spectrum of needs
  • May lead CAPA investigations and dispositions NCMR’s
  • Supports product design transfers to manufacturing
  • May lead and/or participate in Risk Analysis activities at various phases of development, prototyping and commercialization
  • Participates in defining the data to be measured and tracked, provides reports on production stability and periodic updates to Risk Management
  • Implements quality systems, controls and procedures for an efficient and compliant manufacturing function

REQUIREMENTS

  1. Bachelor’s Degree in Engineering is required; ChE is preferred
  2. Experience with Med Device manufacturing for 2+ years, prefer it includes clean room manufacturing
  3. Demonstrable experience drafting and executing protocols concurrent to regulations
  4. Experienced with CAD systems (e.g. SolidWorks), proficient with the MS Office Suite
  5. Hands-on experience with machine setup, production, troubleshooting and/or process improvement a plus
  6. Must be a results oriented quick learner responsive to the needs of the team and with a strong track record of meeting both cost and timeline deadlines
  7. Experienced working cross-functionally with Research & Development, Operations, and Quality Assurance
  8. Ability to read blueprints with a good background in GD&T
  9. Knowledge and experience in test methods including Gage R&R and DOE
  10. Lean Six Sigma training/certification highly valued
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