**Onsite Role**
Job opportunity with a top biopharmaceutical company that is looking for an Engineer IV/Lab Lead to join its team on a 12-month contract with a possibility for conversion or extension!
Qualifications:
- 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).
Job Description/Skills:
- 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 benchtop 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.
Benefits/Perks:
- 401k
- Health Insurance
Please apply here directly if interested but If you are genuinely not interested, is there someone you can recommend?