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Device Development Lab Supervisor (343C)
New Haven, CT

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Contract


Job Type: W-2 Contract

Duration: 12 months

Location: New Haven, CT

Background check required before onboarding

 

Job Overview

Our client is seeking a Device Development Lab Supervisor, who will support technical design and development activities for device and combination products and assist with technology transfer.  

 

Responsibilities:

  • Work with device partner vendor in the creation, evolution, optimization and verification of designs and hardware for drug delivery devices, and their associated test equipment.
  • Develop and validate test methods for Device and Combination Product
  • Test mechanical or electromechanical systems on bench top models, during design development and design verification.
  • Conduct characterization for device function, assembly, manufacturability, etc. using both CAE and traditional Engineering techniques.
  • Analyze data with statistical tools (Minitab, JMP, etc.)
  • Liaise with third parties such as specialist manufacturers, and toolmakers.
  • Design Fixture with Cad software (SolidWorks, ProE)
  • Help assess and develop innovative container closure systems.
  • 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. 

 

NOTE:

The duties of this role are generally conducted in a lab environment.  As is typical of a lab-based role, person must be able, with or without an accommodation to: lift/carry 15-30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/de-gown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. 

 

Skills and Experience:

  • Bachelor’s degree in Engineering (Biomedical, Chemical, Mechanical, or Electrical Engineering) plus 6+ years of experience in medical device development.
  • Experience in design control activities.
  • Knowledge of primary containers and drug delivery.
  • 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).  
  • Experience with injector based combination product preferred. 

 



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