Job Type: W-2 Contract
Duration: 12 months
Location: New Haven, CT
Background check required before onboarding
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.
- 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.
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.