Software Validation Engineer

Software Quality Engineer II

Location:

Lafayette, CO 80026

Contract:

9/21/2026 – 3/19/2027

Work Model:

Hybrid preferred — 4 days onsite/week

Product Line:

CST, AiBLE – Converged Planning products and future product pipeline

What the client is looking for

This is a Software Quality Engineering role supporting both medical-device software development and commercially available software products

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The candidate will work closely with R&D and Quality teams to support software quality processes, procedures, requirements, design, testing, verification, validation, and compliance.

Top 3 Required Technical Skills

• Design Quality Engineering – IEC 62304 Medical-device software quality

• Software lifecycle processes

• Design controls, verification/validation, traceability

• QMS Processes & Procedures

  Quality Management System

• Software quality procedures

• Process compliance and documentation

• Requirements and design reviews

• Cloud-Based Software Support

  Experience supporting cloud-based software products

• Commercial software/product support

• Working with cross-functional software teams

Key Responsibilities

• Develop, modify, and maintain software quality standards, processes, and procedures

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• Evaluate software activities including requirements, design, development, documentation, integration, testing, verification, and validation

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• Support software quality programs and ensure compliance with project/process requirements.

• Review software design and change specifications against applicable quality and process requirements.

• Support requirements traceability and testability

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• Provide or coordinate software verification and validation activities.

• Ensure project and process documentation meets applicable requirements.

• Work cross-functionally with R&D, Quality, and other stakeholders

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• Identify process improvements and recommend enhancements where needed.

• Work independently on moderately complex assignments and contribute to project milestones.

• May provide guidance to junior/entry-level professionals.

Ideal Candidate Profile

Look for someone with:

Software Quality + Medical Device + IEC 62304 + QMS + Cloud Software