Remote Med Device SW Design Quality Engineer

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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

As a Remote Med Device Software Design Quality Engineer at Kforce Inc., you will be instrumental in ensuring the quality and safety of medical device software. Your primary responsibility will involve the application of quality engineering principles throughout the software development lifecycle, including requirements definition, design, implementation, verification, and validation. You will collaborate with cross-functional teams to identify risks, implement process improvements, and ensure compliance with regulatory standards, all while working in a flexible remote environment that promotes innovation and professional growth.

Job Responsibilities

• Develop and manage quality plans and risk management activities specific to medical device software.
• Conduct software design reviews, providing feedback and guidance to ensure compliance with quality standards.
• Perform audits and assessments of software development processes and documentation.
• Collaborate with software development teams to ensure quality control and assurance practices are followed.
• Design, implement, and document verification and validation strategies for software applications.
• Participate in root cause analysis for software defects, facilitating corrective and preventive actions.
• Ensure compliance with applicable regulatory requirements including FDA, ISO 13485, and IEC 62304.

Qualifications

• Bachelor's degree in Engineering, Computer Science, or related field.
• Minimum of 3 years of experience in software quality assurance or quality engineering within the medical device industry.
• Strong understanding of risk management principles and quality standards related to medical devices.
• Proficiency in verification and validation processes, testing methodologies, and quality management systems.
• Excellent analytical and problem-solving skills with a keen attention to detail.
• Strong communication skills to effectively collaborate with cross-functional teams.
• Familiarity with industry regulations, including FDA guidelines and ISO standards.

Technologies & Tools

This position requires proficiency in various technologies and tools that enhance software quality engineering processes. Familiarity with software testing and automation tools such as JIRA, TestRail, and Selenium is preferred. Additionally, expertise in programming languages like Python or Java may be beneficial, along with an understanding of software development methodologies such as Agile and Waterfall. Knowledge of continuous integration/continuous deployment (CI/CD) tools would also be advantageous in promoting efficient software quality practices.

Ideal Candidates

The ideal candidate for the Remote Med Device Software Design Quality Engineer position at Kforce Inc. will be a detail-oriented individual who thrives in a collaborative environment. They should possess strong critical thinking abilities and a proactive approach to problem-solving. A passion for quality assurance in the medical device field, coupled with effective communication, will be crucial for success. Candidates that demonstrate adaptability and a commitment to continuous improvement will align well with our organizational values and contribute significantly to our mission of delivering safe and effective medical devices.