R-D Engineer I - Exempt

Three Point Solutions

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

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Vacancy posted 6 hours ago

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