R&D Engineer
8322 Eagle Palm Drive Riverview, FL 33568 US
Job Description
Duties:
Research and Development Engineering is responsible for developing and implementing new products & processes through adherence to established Design Control processes following current Good Manufacturing Practices (cGMP) and good documentation practices for medical devices.
The R&D Engineer will work on assigned projects to design, develop, validate & qualify products, equipment and processes for manufacturing to support the Design History File.
- Design and develops improvements to equipment & product/ process designs, including integration of advanced technologies.
- Write and execute engineering tests and verification/ validation protocols and reports.
- Assist with technical documentation updates according to assigned project requirements.
- Use and understand Statistical based software and Quality tools.
- Work with Engineering, Operations and Quality as needed to support new equipment, processes or products.
- Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks.
- Works on projects of moderate scope and complexity.
- Identifies possible solutions to a variety of technical problems and takes actions to resolve.
- Applies judgment within defined parameters.
- Receives general guidance may receive more detailed instruction on new projects.
Skills:
- Engineering bachelors degree or equivalent experience in related field required
- 2+ years related work experience preferred
- Experience in regulated industry (i.e. medical devices or pharmaceuticals) preferred
- Ability to work independently and as a member of a team
- Bachelors degree in Chemical, Mechanical or Biomedical Engineering discipline preferred.
Additional:
- Conduct verification & validation testing to support product & process development using risk-based approach.
- Work with engineers and operations to develop and improve quality of production processes, increase productivity and improved safety.
- Develop and execute test methods for measurement equipment & systems.
- Conduct testing of prototype products to verify functionality & design requirements.
- Participate in executing the development and cross-functional project tasks.
- Experience and proficiency providing data analysis and writing technical reports.
- Experience with SolidWorks or similar CAD/CAM software.
- Ability to read and interpret equipment/component manuals, descriptions, diagrams, schematics, and specifications.
- Strong analytical, interpersonal and communication skills.
- Ability to select and safely utilize proper tools for manufacturing equipment design and measurement tools for manufacturing or test settings.
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