Job ID: JOB_ID_1202
Role Overview
The Test Engineer for Medical Devices role in Irvine, California, represents a pinnacle opportunity for engineering professionals dedicated to the healthcare sector. Irvine is globally recognized as a premier hub for medical technology innovation, housing some of the world’s most influential healthcare companies. In this role, you will be at the forefront of ensuring that complex medical systems meet the highest standards of safety and efficacy. Your daily activities will involve a deep dive into the Software Development Life Cycle (SDLC) specifically tailored for medical devices, governed by the IEC 62304 standard. This involves not just finding bugs, but understanding the risk architecture of the device. You will be responsible for both verification—ensuring the product is built correctly according to specifications—and validation—ensuring the right product was built to meet user needs.
Key Responsibilities
- Execute comprehensive testing protocols for medical device software and hardware systems.
- Develop and maintain test cases based on system requirements and design specifications.
- Perform white-box testing to evaluate internal structures and black-box testing for functional requirements.
- Ensure all testing activities comply with IEC 62304 standards for software life cycle processes.
- Collaborate with cross-functional teams including R&D, Quality Assurance, and Regulatory Affairs.
- Document test results and maintain detailed records for regulatory submissions and audits.
- Identify, log, and track defects using industry-standard bug tracking tools.
- Participate in risk management activities according to ISO 14971.
Technical Environment and Standards
The technical environment requires proficiency in both white-box testing, where you examine the internal logic of the code, and black-box testing, where you focus on functional outputs. Given the regulatory landscape, your documentation must be impeccable, adhering to ISO 13485 quality management systems. You will work with hardware-in-the-loop (HIL) simulations and physical prototypes, testing for electrical safety under IEC 60601 and laboratory equipment standards under IEC 61010. This position is onsite five days a week, allowing for direct collaboration with hardware engineers and immediate access to testing laboratories. Candidates should possess a strong academic background in Biomedical or Electrical Engineering, as the role requires an understanding of signal processing and sensor integration.
Industry Impact and Career Growth
Over the long term, this contract offers the chance to see a product move from the late stages of development through to clinical trials and market release. The ideal candidate is someone who views testing not as a final step, but as an integral part of the design process, contributing to the overall safety culture of the organization. By joining this project, you are contributing to technologies that will improve patient outcomes and save lives across the globe. The medical device industry in Southern California is thriving, and this role provides a significant stepping stone for engineers looking to specialize in high-stakes, regulated environments. You will gain exposure to cutting-edge diagnostic and therapeutic tools, working alongside some of the brightest minds in the field. The emphasis on IEC standards ensures that your skills remain highly marketable and relevant as global regulations continue to evolve. We value engineers who are proactive in identifying potential failure modes before they reach the patient, embodying a “quality-first” mindset in every task. Furthermore, the role involves participating in design reviews and providing feedback on testability. You will be expected to stay current with the latest testing methodologies and tools, potentially introducing automation where appropriate to increase efficiency. The collaborative nature of the Irvine office fosters a culture of continuous learning and professional development. This is a long-term engagement designed for those who want to make a lasting impact on the future of medical technology.
Special Requirements
5 days onsite. Domain: Medical Devices. Standards: IEC 62304, IEC 60601/61010, ISO 13485.
Compensation & Location
Salary: $115,000 – $165,000 per year
Location: Irvine, CA
Recruiter / Company – Contact Information
Recruiter / Employer: Quantum World Technologies Inc.
Email: vinit.t@quantumworldit.com
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