R&D Sustaining Engineer I (SolidWorks) — Medical Devices

Lancesoft; Lafayette (CO); On-site; USD 65,000 - 85,000; Full time

Job summary

Lafayette, CO-based role with Lancesoft supporting Airways disposable medical devices currently on the market. Focus on sustaining engineering, testing, validation, and design controls to ensure product quality.

You will work with cross-functional teams to research components, materials, and applications, perform design changes as needed, and assist in CAPA investigations, while adhering to FDA-controlled environment requirements.

Qualifications

• Must Have CAD – Solidworks proficiency (3D models and 2D drawings) and lab instrument use.
• Nice to Have DVT/Design Verification Testing experience in medical devices and clinical settings.
• Sustaining engineering experience with MoC programs, product design, and project management.

Responsibilities

• Support Airways disposable medical devices on the market through testing, validation, and design controls.
• Manage design history files, determine test requirements, and coordinate V&V testing.
• Implement moderate design changes to improve performance and address quality issues.
• Support complaint investigations and root cause analyses, providing corrective solutions.
• Collaborate with clinicians on technical issues and communicate solutions.

Skills

CAD Solidworks

Laboratory instruments

Design Verification Testing

Education

BSME / Biomedical Engineering

Job description

Lafayette, CO-based role with Lancesoft supporting Airways disposable medical devices currently on the market. Focus on sustaining engineering, testing, validation, and design controls to ensure product quality.

You will work with cross-functional teams to research components, materials, and applications, perform design changes as needed, and assist in CAPA investigations, while adhering to FDA-controlled environment requirements.