Medical Device Software Quality Engineer

Los Angeles, CA

Industry: Medical Device Job Number: 131794


Medical Device Software Quality Engineer

Job Description: 
This position is responsible for leading Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development initiatives. This includes ensuring that the software development process is compliant with applicable standards, regulations and guidance documents for medical devices. The ability to effectively communicate software and design and development regulations, optimize the development process, and ensure ambiguities and conflicting requirements are resolved are critical to the success of the position. They will be focusing on validating and testing an “ Allen-Bradley” PLC (Programmable logic controller) equipment. This individual will need to understand manufacturing processes, process automation, and process instrumentation. They need to be familiar with IEC 62304 standards and regulations pertaining to the life cycle requirements of their device software.

 

Responsibilities:
• Lead Design Control and Software Development initiatives to develop appropriate Design History File documents for FDA Class II and Class III medical devices, mobile applications, cloud based systems, and cybersecurity.
• Analysis of software contributing to hazardous situations, Risk control measures, verification of risk control measures, and risk management of software changes.
• Lead Risk Management Activities in accordance with ISO 14971 and software risk requirements in IEC 62304.
• Ensures compliance to IEC 62304, and FDA Guidance on Software Contained in a 510(k) Submission.
• Establish and maintain software quality assurance programs, processes, procedures and controls to ensure compliance with FDA regulations and established standards such as IEC 62304.
• Review requirements, specifications, product design documents, validation protocols, test plans, test cases, and other documentation as required and provide timely feedback.

 

Required:

-  IEC 62304 knowledge working with electro-mechanical devices with embedded software

Plus:

- Allen Bradley & PLC experience

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