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.

Overview

The Remote Med Device Software Design Quality Engineer at Kforce Inc. is responsible for ensuring the safety and effectiveness of medical device software throughout its lifecycle. This role involves collaborating with cross-functional teams to implement, verify, and validate software quality processes that comply with regulatory standards and organizational policies. The successful candidate will provide guidance on design control, risk management, and testing for software developed for medical devices, ensuring adherence to best practices in software quality assurance and contributing to the overall product quality and compliance objectives.

Job Responsibilities

• Develop, implement, and maintain software quality assurance plans for medical device software.
• Conduct software validation and verification activities to ensure compliance with applicable regulatory requirements.
• Collaborate with software development teams to facilitate design control processes and risk management activities.
• Review and approve software design documents, test protocols, and reports.
• Perform root cause analysis of software defects and coordinate corrective actions.
• Participate in audits and inspections, ensuring adherence to QMS requirements and practices.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, or a related field.
• Minimum of 3 years of experience in software quality assurance within the medical device industry.
• Strong knowledge of design control processes, FDA regulations, and ISO 13485 requirements.
• Experience with software development life cycle (SDLC) models and methodologies.
• Proficient in risk management principles as applied to medical device software.
• Excellent analytical, problem-solving, and communication skills.

Technologies & Tools

The Remote Med Device Software Design Quality Engineer will utilize a range of technologies and tools including software project management tools (e.g., JIRA, Confluence), testing frameworks, and statistical analysis software. Familiarity with programming languages and development environments, as well as specialized software validation tools, will also be essential in this role.

Ideal Candidates

Ideal candidates for this position will possess a keen attention to detail and a methodical approach to quality assurance. They will be proactive in identifying software quality improvement opportunities and demonstrate strong interpersonal skills to work effectively in a team environment. Successful applicants will exhibit a passion for medical technology, a commitment to regulatory compliance, and the ability to adapt to a fast-paced, evolving industry landscape.