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R-D Engineer I

Boulder, CO 80301

Posted: 02/04/2025 Employment Type: Contract Job Category: Engineering Job Number: 617481 Is job remote?: No Country: United States

Job Description

  • Perform Design verification testing in Laboratory environment.
  • Update Product Design documentations in moderated changes such as Design History files, V&V testing report and protocols, Product Requirement documents adhering to design controls.
  • Makes minor changes in systems and processes to address Quality issues.

Top 3 technical  skills that are required for the role:
  1. 1. Knowledge of Design Verification testing and its documentation.
  2. Knowledge of Quality, Regulatory requirements, Proficiency in Excel & Word applications.
  3. CAD – Solidworks.

 

Education Required:

Mechanical Engineer, Biomedical Engineer, Electrical Engineer.

 Years’ Experience Required:

0-1


SUMMARY OF POSITION:  

Within the Airways R&D sustaining engineering group, the sustaining engineer’s primary responsibility will be to support Airways disposable medical devices currently on the market.  The sustaining engineer will research, test and validate components, materials and applications while sustaining current product designs.  The R&D Engineer I is responsible for the design history files, determining test requirements, V&V testing and/or coordinating V&V testing, and design controls. In addition to implementing moderate design changes that either enhance performance or address quality issues, the sustaining engineer supports/ performs complaint investigations, determines root cause failure modes and provides solutions for these product lines. 

Responsibilities may include the following and other duties may be assigned. Designs, develops, analyzes, troubleshoots and provides technical skills during research and/or product development. Designs studies to investigate specific life science questions within field of expertise. May be involved in product research and development and/or clinical trials. Translates research discoveries into usable and marketable products.

Generates Engineering Change Orders to support product sustaining efforts.
The R&D Engineer I is responsible for the design history files, determining test requirements, V&V testing and/or coordinating V&V testing, and design controls.
In addition to implementing moderate design changes that either enhance performance or address quality issues, the sustaining engineer supports/ performs complaint investigations, determines root cause failure modes and provides solutions for these product lines.
  • Follows strict adherence to policies and procedures associated with an FDA controlled environment. 
  • Prepares analysis reports for managers, project leaders or other personnel. 
  • Solid working knowledge of quality and regulatory requirements.
  • Works on moderate engineering tasks and has constant feedback from their Supervisor.  
  • Sustaining engineering MoC programs, product design and project management experience. 
  • CAD – Solidworks proficiency (3d moldes and 2d drawings). 
  • Problem solving, priority setting, customer focus and driving for results 
  • International travel to Design Centers, Manufacturing plants and Contract manufacturing facilities. 
  • Labeling changes.
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About Boulder, CO

Ready to kickstart your career in the stunning Boulder, Colorado area? Known for its vibrant arts scene, world-class dining options, and stunning outdoor spaces like the iconic Flatirons and Chautauqua Park, this location offers unparalleled growth opportunities and a unique work-life balance that's hard to beat. You'll find yourself immersed in a community that values innovation, sustainability, and creativity, with renowned galleries like BMoCA, top-rated restaurants, and the captivating Colorado Shakespeare Festival at your doorstep. Explore job opportunities in this bustling region today and discover why Boulder is not just a place to work, but a place to thrive.

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