Enigneer/Lab Technician - Talent Space

Talent Space, Inc. is seeking a Engineer/Lab Technician for a contract opportunity in New Haven, CT!

Responsibilities:
Support technical design and development activities for device and combination products and assist the technology transfer.

• Manage medical device test method and specification development, including test method development, validation, transfer, and life cycle management.
• Support the laboratory operation such as sample inventory, equipment qualification and maintenance.
• Conduct characterization for device function, assembly, manufacturability, etc. using both CAE and traditional engineering techniques. 
• Test mechanical or electromechanical systems on bench top models or production representative units, during design development and verification. 
• Consult with third parties such as specialist manufacturers and toolmakers. 
• Communicate effectively, both verbally and in writing, internally across departments and with external suppliers. 
• Comply with the Company’s quality assurance requirements as well as applicable regulatory requirements. 

 
Required Skills:

• Bachelor’s degree in Engineering (Biomedical, Chemical, Mechanical, or Electrical Engineering) plus 1-to-3-year experience in laboratory. (preferred)
• Experience in design control activities. 
• Understanding of mold, fixture design and build as well as application of validation processes (IQ/OQ/PQ). 
• Interface with the medical device vendor and tooling company. 
• Knowledge of the regulatory and compliance requirements of device design controls and combination products (i.e. FDA QSR 21 CFR Part 4 and 820/ISO13485 quality system requirements). 
• Manufacturing, device design, fixture design experience
• CAD – Computer aided design – Solidworks software