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Three Point Solutions, Inc.
R&D Sustaining Engineering
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Job Description
Job Title:
R&D Sustaining Engineer Client:
Medical Device Manufacturing Duration:
12
Months Contract Contract Location:
Lafayette, CO 80026
•Preferred US Citizens or Green card holder Job Summary Support sustaining engineering for disposable medical devices currently on the market. Work on testing, validation, design changes, quality issues, material/component research, and product improvements in an FDA-regulated environment. Key Responsibilities Support sustaining engineering for existing medical devices. Develop and execute Design Verification (DV) and Validation (V&V) testing. Define test requirements, 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 for RoHS, Prop 65, and Materials of Concern compliance. Maintain Design History Files (DHF), Design Controls, and engineering documentation. Collaborate with Clinical, Manufacturing, Quality, and Regulatory teams. Required Skills & Qualifications 1 year of engineering experience. SolidWorks - 2D & 3D. Knowledge/experience with laboratory instruments. Academic or practical 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 and Design Controls. CAPA and Root Cause Analysis. Quality & Regulatory requirements. Engineering Change Orders (ECOs). Test methods and tooling. Product lifecycle knowledge. Basic AI tools, Agents, and Flows. Education B.S. in Mechanical Engineering or Biomedical Engineering. This job can be searched as, research, chemical engineer, chemistry, r&d engineer, research scientist, mechanical engineer IND_
ENG Pay:
$30.00 - $34.00 per hour Expected hours: 40.0 per week Application Question(s): Are you a US Citizen or a Green card holder ?
Experience:
Design Verification/V&V:
1 year (Required)
SolidWorks:
1 year (Required) Regulatory industry: 1 year (Required)
Work Location:
In person