Software Validation Engineer

Grove Technical Resources; Colorado; Hybrid; USD 90,000 - 130,000; Full time

Job summary

Grove Technical Resources is seeking a Software Quality Engineer to support medical-device software development and commercial software products in a hybrid, mostly on-site environment.

You will collaborate with R&D and Quality teams to drive software quality processes, requirements, design, testing, verification, validation, and regulatory compliance across cloud-based software.

Qualifications

• Experience with IEC 62304 and medical-device software quality.
• Experience with software lifecycle processes.
• Experience with QMS processes & procedures.
• Experience supporting cloud-based software products.
• Ability to work with cross-functional software teams.

Responsibilities

• Develop, modify, and maintain software quality standards, processes, and procedures.
• Evaluate software activities from requirements to validation.
• Support software quality programs and ensure compliance with project requirements.
• Review design and change specifications against quality requirements.
• Support requirements traceability and testability.
• Provide or coordinate software verification and validation activities.
• Ensure project documentation meets applicable requirements.
• Work cross-functionally with R&D, Quality, and other stakeholders.
• Identify process improvements and enhancements where needed.
• Work independently on moderately complex assignments and mentor juniors.

Skills

IEC 62304 medical-device quality

Software lifecycle processes

QMS processes & procedures

Cloud-based software support

Cross-functional teamwork

Job description

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.

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 62304Medical-device software quality
• Software lifecycle processes
• QMS Processes & ProceduresQuality Management System
• Software quality procedures
• Process compliance and documentation
• Requirements and design reviews
• Cloud-Based Software SupportExperience 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.
• Evaluate software activities including requirements, design, development, documentation, integration, testing, verification, and validation.
• 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.
• 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.
• 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