R-D Engineer I - Exempt

Join our innovative team at our Lafayette, CO location, where you'll have the opportunity to work in a dynamic and collaborative environment. As part of our Airways R&D sustaining engineering group, you'll play a crucial role in supporting our disposable medical devices currently on the market. Enjoy the beautiful surroundings and vibrant community of Lafayette while contributing to life-saving products.

Must Have

• CAD – Solidworks proficiency (3D models and 2D drawings)
• Laboratory common instruments use

Nice to Have

• Conducted DVT Design Verification Testing
• Medical Device and clinical environment experience
• Sustaining engineering Material of Concerns (MoC) programs, product design, and project management experience

Top 3 Technical Skills Required

• CAD – Solidworks (3D and 2D)
• Laboratory common instruments use
• Execution of Design Verification Testing

Education Required

BSME (Bachelor of Science in Mechanical Engineering) or BS BME (Bachelor of Science in Biomedical Engineering)

Years’ Experience Required

0-1

Work Schedule

40 Hours/week

Location

Minimum 4 days/week on Lafayette campus site, depending on testing requirements it can be 5 days/week on site.

Product Line Support

Airways: Endotracheal Tubes and Tracheostomy Tubes

Summary of Position

The 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. Responsibilities include managing design history files, determining test requirements, coordinating V&V testing, and design controls. The engineer will implement moderate design changes to enhance performance or address quality issues, support complaint investigations, determine root cause failure modes, and provide solutions for these product lines.

Essential Functions

• Provides technical support for existing products by developing solutions for moderately complex problems with a high level of accountability.
• Maintains product performance and quality for existing products by leading and assisting with issues relating to CAPAs, customer complaints, and manufacturing processes.
• Supports research on raw materials, components, and assemblies for MoC compliance.
• Adheres to policies and procedures associated with an FDA-controlled environment.
• Generates Engineering Change Orders to support product sustaining efforts.
• Works with clinicians on technical issues and communicates solutions appropriately.
• Identifies immediate solutions for short-term corrections to prevent impact on business goals.

Preferred Skills/Qualifications

• Experience with internal and outsourced sustaining development projects
• Ability to partner with cross-functional organizations to drive the business
• Solid working knowledge of quality and regulatory requirements
• Strong communication skills, both verbal and written
• Multi-tasking, problem-solving, and organizational skills
• Good documentation practices

Skills/Competencies

• Problem-solving
• Priority setting
• Customer focus
• Driving for results

Other Skills

AI Artificial Intelligence basic knowledge to use common tools, agents, flows, etc.