- Provide guidance and input regarding product development.
- Develop and commercialize devices including interfaces with the primary container.
- Provide guidance and input regarding product development
- Regularly interface with staff and leaders in Commercial Marketing, Clinical Sciences, Contract Manufacturing, Product Core Teams, Pharmaceutical development, Packaging Development, Quality and Regulatory Affairs
- Regularly interact with external development partners and components suppliers
- Plan and execute test-method validation projects, including developing, performing, and documenting test-method validation activities in accordance with cGMP requirements.
- Write and execute protocols and reports, including integrating the use of appropriate statistical tools in validation protocols, and applying training materials for test methods.
- Generate/execute equipment qualification (IQ, OQ, PQ) protocols, provide input, and execute plans to ensure robust equipment operation and data management, and direct others in the execution of protocols.
- Design Controls
Application of relevant modeling and design tools, design controls and/or statistical analysis.
- Engineering: Electro-mechanical system design, System engineering, Process/Industrial Engineering
- Modeling: Monte Carlo Simulations, Tolerance Analysis, Finite Element Analysis.
- Device Design: CAD, Rapid prototyping, GD&T, Material selection & Biocompatibility, Design for Manufacturability, Molding.
- Full data and statistical analysis (JMP, Minitab) and Design of Experiments.
- Design Controls for regulatory compliance & filing (ISO 13485, etc): GDP/GLP/GMP, Design History Files, protocols/reports, hazards analyses, batch records, etc..
- Six Sigma (Green/Black Belt): DMAIC and DFSS.
- Human Factors Evaluations: User needs research, Usability engineering and associated risk analyses
· B.S, M.S, Ph.D or advanced degree in Engineering, with preference for Mechanical Engineering,
Materials Science Engineering Electrical Engineering, Chemical Engineering, or the equivalent.
· At least 5 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelors degree.