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 Dice, 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 Dice will be instrumental in ensuring that our software products meet the stringent quality standards essential for the medical device industry. This role involves collaborating with cross-functional teams to define, develop, and implement software quality processes, performing risk assessments, as well as facilitating compliance with regulatory standards. The engineer will play a critical role in the overall software development lifecycle, ensuring that our products not only meet user needs but also adhere to safety and performance criteria mandated by industry regulations.

Job Responsibilities

• Develop, implement, and maintain software quality assurance processes for medical device software.
• Conduct requirements analysis, risk management, and design reviews to ensure compliance with applicable regulations.
• Perform software verification and validation activities, including test planning, execution, and reporting.
• Collaborate with product development teams to integrate quality practices throughout the software development lifecycle.
• Assist in the preparation of regulatory submissions, responses to inquiries, and audits.
• Identify process improvement opportunities and implement corrective and preventive actions.
• Stay updated with industry standards and best practices related to software quality in medical devices.

Qualifications

• Bachelor’s degree in Computer Science, Engineering, or a related field.
• Minimum of 3 years of experience in software quality assurance or control, preferably in the medical device industry.
• Strong understanding of regulatory requirements related to medical devices, such as ISO 13485, IEC 62304, and FDA regulations.
• Proficiency in software development methodologies, including Agile and Waterfall.
• Experience with testing tools, defect tracking systems, and documentation tools.
• Excellent analytical, problem-solving, and communication skills.

Technologies & Tools

The Remote Med Device SW Design Quality Engineer will utilize various technologies and tools essential for software quality assurance processes. This includes software testing tools such as Selenium and JIRA for defect tracking, as well as document management systems to maintain compliance documentation. Familiarity with programming languages such as Python or C++ may also be required for automation testing purposes. Additionally, the engineer will leverage collaboration tools such as Slack and Microsoft Teams to facilitate effective communication across teams.

Ideal Candidates

The ideal candidates for the Remote Med Device SW Design Quality Engineer position will possess a meticulous attention to detail and a passion for quality in software design. They should be proactive in identifying potential issues and driven to implement innovative solutions. Strong communication and collaboration skills are essential, as the role requires frequent interaction with diverse teams. Furthermore, candidates should have a robust background in regulatory compliance and a commitment to maintaining the highest industry standards in the development of medical devices.