Functionality Device Engineer

Gaithersburg, MD 20878

Posted: 01/30/2019 Industry: Other Area(s) Job Number: 33540

Functionality Device Engineer

The role will be part of the Dosage Form Design and Development group working on combination product development, development of novel technologies, and transforming scientific knowledge / analysis into practical implementations. The Engineering Project Manager will identify, evaluate, and develop solutions for digital connectivity integration (internal and external) within mechanical and electro-mechanical delivery systems. Digital connectivity integration will integration of mechanical and electronic systems. Desirable for candidate to have previous experience with mechanical engineers and mechanical device experience as well as experience working with electronics engineers and electronics systems. Under minimal supervision, the candidate will manage and accomplish assigned projects in a timely fashion and to agreed quality standards. Apply knowledge and expertise to take responsibility for ensuring appropriate and robust test methods are developed and qualified in support of device development projects. Proactive in proposing innovative ideas and solving complex problems. 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. Assess and report data with a clear understanding of its reliability, interpret findings and draw authoritative conclusions and recommendations so that their significance can be appreciated. Present findings at internal/external meetings, prepare manuscripts and patent applications. Establish and maintain a close working relationship with equipment vendors and contribute to oversite of external collaboration partners. Liaise effectively with internal departments (Quality, Regulatory, Operations, etc…). Manage the transfer of developed test methods to internal and external quality control testing sites. Plan and manage device DV and stability testing. Ensure that work is performed in accordance with appropriate quality and compliance standards, e.g. ISO/ASTM/MDD/GMP/GLP, 21CRF820.30 and applicable safety requirements. Prepare and maintain documentation and formal reports in accordance with these standards. Prepare formal reports and contributions to regulatory documentation. Keep the various process description documents up to date and contribute to the tech transfer documentation as required. Present data at the team and Department meetings as required. Maintain and contribute to Quality Systems 21CFR820.30 and ISO 13485 within the group to ensure consistency and conformance with GxP working practices

Requirements:

Experience with combination products (such as inject-able product development such as auto-injectors, pre-filled syringes, etc.).

Experience with GxP in a product development environment /setting is required.

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.

equirement: 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. 
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