Senior Software Quality Engineer, Medical Device Design

Planet Pharma; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Planet Pharma seeks a Senior Software Quality Engineer to ensure quality and regulatory compliance across software and system design activities for neurovascular device software. You will partner with cross‑functional teams to plan, execute, and document design controls in line with medical device standards.

The role emphasizes risk management, verification/validation, and regulatory readiness throughout the design lifecycle, with a focus on delivering safe, effective products for patients.

Qualifications

• Experience with design controls, software lifecycle, and verification/validation.
• Strong understanding of risk management and traceability across requirements, design and testing.
• Ability to collaborate with cross‑functional teams in a regulated environment.

Responsibilities

• Provide design quality support for software and software‑as‑a‑medical‑device development programs from concept through transfer to manufacturing.
• Ensure compliance with design control, software lifecycle, and risk management requirements.
• Review system and software requirements, architecture, and design documentation.
• Develop verification and validation strategies for software, system, and integration testing.
• Partner with engineering, regulatory, and quality teams to resolve design quality issues.
• Participate in design reviews and mentor junior engineers on quality practices.

Skills

Software coding experience

Software Risk Assessment

Software Verification and Validation

Education

Bachelor’s or Master’s in Engineering

Job description

Planet Pharma seeks a Senior Software Quality Engineer to ensure quality and regulatory compliance across software and system design activities for neurovascular device software. You will partner with cross‑functional teams to plan, execute, and document design controls in line with medical device standards.

The role emphasizes risk management, verification/validation, and regulatory readiness throughout the design lifecycle, with a focus on delivering safe, effective products for patients.