Engineering Support Specialist
101 Orchard Ridge Dr North Potomac, MD 20878 US
Job Description: Summary of the Group:
The position is in the Device Functionality and Safety group (Device Lab) within the Device Department. Device Development provides combination product expertise to the development of drug-delivery parenteral for the expanding Client pipeline. We are seeking a device engineer to join the Device Functionality and Safety team. The group consists of people with a diverse range of technical backgrounds including device engineers, people with equipment and test method development expertise, design controls skills and more and is responsible for successful completion of design, development and commercialization deliverables and ensuring that device design, component selection, manufacturability and testing specifications and methods meet product needs. The team is working on characterization, evaluation, and design verification of combination devices and novel technologies. Main Duties & Responsibilities: The candidate will be responsible for the following activities:
- Design, develop and execute experiments (DOE) for device characterization and evaluation with minimum supervision.
- Make detailed observations, data analysis, interpret results, maintain documentation, and prepare technical reports, summaries, SOP, protocols, and reports with minimum supervision.
- Deliver timely, high quality data and interpretations to drive key scientific solutions.
- Is expected to be familiar with medical device development and preferably combination devices.
- 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).
- Be proficient in 3D design and modeling fixtures using Solidworks
- Be a skilled user of device engineering and testing software/tool/equipment such as the tensile test machine (INSTRON), confocal and/or light microscopy, Minitab, and etc.
- Develop process descriptions to standardize testing procedures across analysts.
- Innovate, develop and evaluate device characterization techniques and technologies as they relate to device development requirements.
- Perform test method qualification and method transfer to GMP testing group in support of device verification & validation testing.
- Establish and foster a strong collaborative working relationship with internal departments and external vendors/suppliers.
- Ensure that work is performed in accordance with appropriate quality and compliance standards, e.g. - USP/PharmEur, ISO /MDD/GMP/GLP, 21CRF Part 4 & 820.30 and applicable safety requirements. Prepare and maintain documentation and formal reports in accordance with these standards.
- Medical device design - Design Controls
- Combination products
- Regulatory filing of pharmaceutical products
- Mechanical testing
- 3D model and rapid prototyping
- Medical Device Development, Combination Products
- Design Controls
Education/Skills/Experience: B.S. +4 years of relevant experience M.S +2 years of relevant experience
45-50 pay rate range
**salary will be commensurate with experience**
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