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:

  1. Preferred experience with remediation or integration projects

  2. Preferred experience with laser systems and fibers

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