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 be pivotal in ensuring that all software design processes comply with both industry standards and internal quality benchmarks. This role requires a comprehensive understanding of software quality assurance methodologies, as well as active collaboration with software development teams to guarantee that products meet all regulatory requirements and consumer expectations. The successful candidate will conduct risk assessments, design reviews, and verification and validation testing, contributing to the overall improvement of product quality and compliance in the medical device sector.

Job Responsibilities

• Conduct risk assessments and establish risk management documentation in compliance with regulatory standards.
• Participate in design reviews and ensure effective documentation of software design processes.
• Define and execute software verification and validation testing protocols, ensuring releases meet quality standards.
• Collaborate closely with cross-functional teams including hardware engineers, project managers, and regulatory affairs to ensure cohesive product design and compliance.
• Identify and document software defects and discrepancies, facilitating corrective actions.
• Assist in the development and maintenance of quality management system documentation including procedures and work instructions.
• Review and analyze software requirements to ensure comprehensive test coverage.

Qualifications

• A Bachelor’s degree in Software Engineering, Computer Science, Electrical Engineering, or a related field is required.
• A minimum of 3 years of experience in software quality assurance or quality engineering in the medical device industry is preferred.
• Strong knowledge of regulatory requirements applicable to medical devices (e.g., FDA, ISO 13485).
• Experience with software verification and validation methodologies.
• Proficiency in quality management systems and tools.
• Strong analytical skills, with an ability to troubleshoot and solve complex issues.
• Excellent communication skills, both verbal and written, to interact with team members and stakeholders effectively.

Technologies & Tools

The Remote Med Device SW Design Quality Engineer will utilize a range of technologies and tools, including but not limited to software testing tools like Selenium, JIRA for issue tracking, and specific documentation tools aligned with quality management such as MasterControl or TrackWise. Additionally, familiarity with programming languages such as Python or Java may be beneficial for automation testing purposes, along with experience in requirement management tools to ensure comprehensive testing coverage.

Ideal Candidates

Ideal candidates for this position will possess a detail-oriented mindset, demonstrating a strong commitment to quality and compliance in all aspects of their work. They should be proactive problem solvers, able to work independently in a remote environment while still collaborating effectively with various team members. A passion for improving product quality and a genuine interest in the medical device field are essential traits, along with a willingness to adapt to new technologies and methodologies as necessary to remain current with industry standards.