Medical Devices Software Quality Engineer

US Tech Solutions; San Bruno (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

US Tech Solutions is seeking a Software Quality Engineer for a contract role in San Bruno, CA. The position emphasizes quality assurance across the SDLC, regulatory compliance with FDA QSR and ISO 13485, and documentation support for DHF and risk management.

Ideal candidates have 3–5 years of software quality experience in medical devices, familiarity with IEC 62304, and hands-on QA practices. Strong communication and collaboration with cross-functional teams are essential.

Qualifications

• Proven experience in software quality engineering for medical devices.
• Experience with IEC 62304 and ISO 13485-aligned QMS.
• Familiarity with SDLC and regulatory compliance in healthcare software.

Responsibilities

• Act as Quality Assurance champion across the software development lifecycle.
• Ensure compliance with US FDA QSR, ISO 13485, and medical device industry best practices.
• Support DHF creation and maintenance (plans, verification/validation, requirements, risk files).
• Integrate ISO 14971 risk management and IEC 62366 usability engineering into SDLC.

Skills

QMS

SClient

Agile

Scrum

Waterfall

Microservices

Risk Management

DHF

Education

Bachelor’s Degree or equivalent practical experience

Tools

Google Suite

Job description

San Bruno, CA

Contract

Job Description:

• The client is using a data-driven approach to change the way people manage their health and the way healthcare is delivered. The purpose is to bring the promise of precision health to everyone, every day. The client is focused on generating and activating data from a variety of sources, including clinical, social, behavioral and the real world, to arrive at the best solutions for a person based on a comprehensive view of the evidence.

Responsibilities:

Quality Assurance Champion:

1. Act as a champion of Quality Assurance throughout the software development lifecycle, ensuring adherence to high standards and corporate requirements.

Regulatory Compliance:

1. Ensure compliance with US FDA Quality System Regulations, ISO 13485, and integration of best practices from the medical device industry.

Documentation and Support:

1. Support the creation and maintenance of Design History Files (DHF) including development plans, verification and validation plans, requirements specifications, and risk management files.

Risk Management and Usability Engineering:

1. Integrate ISO 14971 risk management and IEC 62366 usability engineering activities with SDLC processes.

Training and Compliance:

1. Provide ongoing training and education on quality systems and SDLC frameworks, and support CAPA, complaints, audits, and overall QMS functions.

Experience:

Medical Device Software Experience:

1. Proven experience in software development for medical devices, specifically focusing on Software as a Medical Device (SClient) or low-risk enforcement discretion products.
2. At least 3-5 years of recent experience in standalone software development, with a solid understanding of medical device software standards such as IEC 62304.

Software Quality Engineering Expertise:

1. Hands-on experience in Software Quality Engineering (QE) rather than hardware or test engineering.
2. Proficiency in applying quality principles throughout the software development lifecycle, including familiarity with SDLC processes and Quality Management Systems (QMS) compliant with US FDA regulations and ISO 13485.

Tool Proficiency:

1. Demonstrated ability to effectively use a variety of tools required for product development and communication, including Google Suite.
2. Experience with diverse tools for quality assurance and engineering tasks, showing adaptability to different environments.

Agile and Microservices Experience:

1. Experience working in an agile development environment, particularly with microservice-based architectures.
2. No background in hardware engineering or test engineering roles (e.g., CSV background or test engineering experience). The focus is strictly on software quality engineering in a software-only context.

Skills:

• QMS
• SClient
• Agile, Scrum or Waterfall.
• Microservices is preferred.
• Risk Management
• DHF

Education:

• Bachelor’s Degree or equivalent practical experience.

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com (http://www.ustechsolutionsinc.com) .

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.