R-D Engineer I - Exempt

Job Title: R&D Sustaining Engineering
Client: Medical Device Manufacturing
Duration: 12 Months Contract with possible extension
Location: Lafayette, CO 80026

Job Description:

Airways R&D Sustaining Engineer supports disposable medical devices currently on the market. They will research, test, and validate components, materials, and applications, while supporting existing product designs, design changes, quality issues, and product improvements.

Key Responsibilities

• Support sustaining engineering activities for existing medical devices.
• Develop and execute Design Verification (DV) and Validation (V&V) testing.
• Determine test requirements, test methods, and tooling.
• Perform failure investigations and root cause analysis.
• Support CAPA, customer complaints, and manufacturing issues.
• Support design changes and Engineering Change Orders (ECOs).
• Research materials, components, and assemblies for RoHS, Prop 65, and Materials of Concern compliance.
• Maintain Design History Files, Design Controls, and engineering documentation.
• Follow procedures within an FDA-regulated environment.
• Collaborate with cross-functional teams, clinicians, manufacturing, quality, and regulatory groups.

Required Qualifications

• BSME (Mechanical Engineering) or BSBME (Biomedical Engineering)
• 0–1 year of experience
• SolidWorks – 2D & 3D
• Experience/knowledge using laboratory instruments
• Experience or academic exposure to Design Verification / V&V Testing
• Strong problem-solving, documentation, communication, and organizational skills
• Ability to multitask, prioritize, and work cross-functionally

Preferred Skills

• Medical Device / FDA-regulated environment
• Sustaining Engineering
• Design Controls
• CAPA
• Root Cause Analysis
• Quality & Regulatory Requirements
• Engineering Change Orders
• Test Methods & Tooling
• Product Lifecycle
• Cross-functional collaboration
• Basic AI tools / Agents / Flows

As a leading contract, contract-to-hire and professional placement firm, Three Point Solution understands the importance of aligning our client with the right resource at the right time. We are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate. Our goal is to cultivate and maintain true partnerships with our clients and candidates.