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 Medical Device Software Design Quality Engineer will play a critical role in ensuring that product development processes meet stringent quality standards and regulatory requirements. This position involves collaborating with cross-functional teams to evaluate and improve software design processes while also ensuring compliance with industry standards. The ideal candidate will monitor software development methodologies, conduct quality audits, and contribute to risk management activities, all while working in a remote setting.

Job Responsibilities

• Develop, implement, and maintain quality assurance processes for software design in medical devices.
• Conduct risk assessments and validate software changes to ensure compliance with regulatory standards.
• Perform audits of software development processes and prepare findings reports for stakeholders.
• Collaborate with engineering teams to identify quality issues and recommend corrective actions.
• Review software development documentation to ensure accuracy and compliance with established quality standards.
• Participate in cross-functional teams to drive continuous quality improvements.
• Stay informed about industry regulations and standards to ensure compliance in all software design efforts.

Qualifications

• Bachelor's degree in Computer Science, Engineering, or a related field.
• Minimum of 5 years of experience in quality engineering, specifically within medical device software development.
• In-depth knowledge of industry standards such as ISO 13485, IEC 62304, and FDA regulations.
• Proficiency with quality management tools and methodologies, including FMEA, CAPA, and root cause analysis.
• Strong analytical skills and attention to detail.
• Excellent communication and collaboration skills.

Technologies & Tools

In this role, the candidate will utilize various technologies and tools including software development environments, quality management systems, and project management software. Familiarity with tools such as JIRA, Document Management Systems (DMS), and statistical analysis software will be important. Additionally, understanding software testing frameworks and methodologies will be crucial for ensuring quality assurance in product development.

Ideal Candidates

The ideal candidate for the Remote Medical Device Software Design Quality Engineer position will exhibit a strong commitment to quality and a proactive approach to problem-solving. They must possess a solid understanding of software development processes while being detail-oriented and highly organized. Strong interpersonal skills and the ability to work collaboratively in a remote environment are essential. Candidates should also demonstrate adaptability to new challenges and a continuous learning mindset.