Framingham, MA , United States
Industry
Mid-Senior Level
English
Key Responsibilities:
- Responsible for engineering documentation
- May train or provide work direction to technicians or contractors
- Designs, procures, reviews, and fabricates tooling and fixtures using Solidworks.
- Designs and coordinates standard engineering tests and experiments.
- Works independently to plan and schedule own activities necessary to meet timelines
- Summarizes, analyzes, and draws conclusions from test results
- Prepares standard reports/documentation to communicate results to technical community
- Works cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing to ensure project success.
- Support test method development & validation activities.
- Performs troubleshooting on design, material, or process-related issues.
Quality Systems Duties and Responsibilities- Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Qualifications:- BS degree in Mechanical, Electrical, Biomedical Engineer, or similar degree and 2+ years of experience
- Preferred experience with Medical Device industry or regulated industry
- Familiar with Design Control methods such as Risk Analysis, Design Validation and Verification plans, protocol and report generation
- Knowledgeable in six sigma practices and methodology
Additional Job Specific Requirements:
- Preferred experience with remediation or integration projects
- Preferred experience with laser systems and fibers