Remote Med Device SW Design Quality Engineer

This job was posted over 30 days ago, so it has most likely closed. See newer jobs like it.

Written by AI from the job title and company, not by Kforce Inc, so some details may not match this job. The employer's own page has the real description.

Job Overview

The Remote Med Device SW Design Quality Engineer at Kforce Inc. will play a pivotal role in ensuring the quality and compliance of software design within the medical device sector. This position entails collaborating with cross-functional teams to establish quality metrics, implement testing strategies, and contribute to risk management processes. The individual will be responsible for verifying that software design meets regulatory standards while fostering an environment of continuous improvement in software development processes.

Job Responsibilities

• Develop and maintain quality assurance processes for software design in compliance with FDA regulations and ISO 13485 standards.
• Collaborate with software engineers to define and document quality metrics and acceptance criteria for software releases.
• Conduct risk assessments and implement risk mitigation strategies throughout the software development lifecycle.
• Create and execute comprehensive test plans, including automated tests where applicable, to validate software functionality and performance.
• Participate in design reviews, providing insights and recommendations for quality improvements.
• Document findings and communicate results to stakeholders, ensuring transparency and traceability throughout the project.
• Provide training and support to team members on quality assurance best practices and regulatory requirements.

Qualifications

• Bachelor's degree in Computer Science, Biomedical Engineering, or a related field.
• A minimum of 3 years of experience in software quality assurance or software engineering within the medical device industry.
• Strong understanding of regulatory requirements, including FDA regulations and ISO 13485 standards.
• Experience with software testing methodologies (manual and automated).
• Proficiency in using quality management tools and techniques, such as FMEA and root cause analysis.
• Knowledge of programming languages such as C++, C#, or Python is a plus.
• Exceptional problem-solving skills and attention to detail.
• Strong communication and interpersonal abilities, capable of working effectively in a remote environment.

Technologies & Tools

The Remote Med Device SW Design Quality Engineer will utilize various technologies and tools essential for quality assurance and software development. These include platforms for implementing automated testing frameworks, quality management software, version control systems like Git, as well as collaboration tools such as JIRA and Confluence for project management and documentation. Familiarity with risk management software and simulation tools is also essential for effective risk assessment and mitigation.

Ideal Candidates

The ideal candidate for the Remote Med Device SW Design Quality Engineer position is a meticulous professional who demonstrates a strong commitment to quality and compliance within the medical device industry. They exhibit excellent analytical skills, enabling them to identify issues and develop effective solutions rapidly. A proactive communicator, this individual effectively collaborates with various teams while being adaptable to changing project requirements. Additionally, they should have a continuous improvement mindset, striving to enhance processes and foster a quality-centric culture within the organization.