Lead Device Development Engineer
282 Washington Street New Haven, CT 06510 US
Device development of products including continuous product improvement within the Development function. The candidate will support technical design and development activities for device and combination products and assist with technology transfer.
You will be responsible for:
• Working with our 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 (GR&R, ...) 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,.)
• 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.
You will need to have:
• 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).
• The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, employees 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.
We would prefer for you to have:
• Bachelor’s degree in Engineering (Biomedical, Chemical, Mechanical, or Electrical Engineering) plus 6+ year experience in medical device development.
Experience with injector based combination product preferred.