Engineer - Combination Products
Bethesda Metro Area, MD
BS, MS, or PhD degree in Mechanical/Electrical/Biomedical/Chemical Engineering, Physics, Pharmaceutical Sciences, or related field.
PhD 0-3 years, MS 2-5 years, and BS 5-7 years of relevant experience.
- Requires understanding and experience of the principles and concepts within the area of device development in the pharmaceutical industry, and is expected to demonstrate up to date technical knowledge.
- Knowledge of relevant compliance systems and experienced in authoring relevant sections in regulatory submissions (IND, IMPD, BLA, MAA etc.).
- Prior experience with electro-mechanical drug delivery and/or medical device system development a plus
- Dosage Form Design and Development group working on combination product development, development of novel technologies, and transforming scientific knowledge / analysis into practical implementations.
- Identify, evaluate, and develop solutions for digital connectivity integration (internal and external) within mechanical and electro-mechanical delivery systems.
- Establish and champion best practices for test method qualification, ISO functionality device testing, and participate in general assessment for biocompatibility assessment.
- Hands on development and qualification of device test methods, fixtures, and custom accessories (which may be electromechanical in nature). Author technical reports and process descriptions as required. Be an accomplished user of Solidworks or similar CAD tool and be an accomplished user of device testing instruments such as INSTRON tensile test machine, Mitutoyo QVX302 optical measurement system, Lansmont transportation simulator, and other engineering tools. Develop process descriptions to standardize testing procedures.
- Be able to design, develop and execute DOE experiments for device characterization. Make detailed observations, data analysis, interpret results, maintain documentation, and prepare technical reports, summaries, SOPs, protocols, and reports with minimum supervision.
- Maintain and contribute to Quality Systems 21 CFR820.30 and ISO 13485 within the group to ensure consistency and conformance with GxP working practices