Develops products, materials, processes, or equipment for projects of moderate complexity.
Under limited supervision/guidance, compiles, analyzes, and reports operational, test, and research data to establish performance standards for newly designed or modified products, processes, and materials.
1. Fully participates in and successfully contributes to project teams typically including the following activities: product design and development, test of materials, preparation of specifications, process capability studies, research investigations (animal and clinical studies), report preparation, and process/test documentation.
2. Works independently to plan and schedule own activities necessary to meet timelines.
3. Designs and coordinates standard engineering tests and experiments.
4. Designs, procures, and fabricates tooling and fixtures.
5. Performs troubleshooting on new products/process problems as related to design, material, or process.
6. Summarizes, analyzes, and draws conclusions from test results.
7. Prepares standard reports/documentation to communicate results to technical community.
8. Responsible for engineering documentation.
9. Invents/ creates concepts and designs for new products/processes, and submits idea disclosures.
10. May train and/or provide work direction to technicians.
11. Works cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing to ensure project success.
12. Demonstrates PDP/TPD system knowledge through delivery of high quality deliverables.
Quality Systems Duties and Responsibilities
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
2 - 4 Years with BS 0 - 2 Years with MS
Required Skill Set:
Mechanical or Biomedical Engineer
2-5 years experience
Engineering experience, developing methods, products, or manufacturing support
Med Device or regulated industry device preferred
Have engineering acumen, collaboration skills, and ability to make/fix
Experience with test method development, experience with medical quality systems, prefer mechanical or biomedical engineer, data processor experience a plus