8322 Eagle Palm Drive Riverview, FL 33568 US
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.
- 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.
- 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.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.