Remote Med Device SW Design Quality Engineer

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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 Software Design Quality Engineer at Dice is responsible for ensuring that software products meet the necessary quality standards and regulatory requirements in the medical device industry. This role involves collaborating with cross-functional teams to develop and implement testing procedures, conducting risk assessments, and contributing to continuous improvement initiatives. The ideal candidate will ensure that all software design processes adhere to industry standards, enhancing product safety and efficacy while maintaining compliance with FDA and ISO regulations.

Job Responsibilities

• Develop and execute software validation and verification protocols for medical devices.
• Conduct risk management activities and document risk analyses in accordance with ISO 14971.
• Collaborate with software development teams to define quality metrics and testing procedures.
• Participate in design reviews and audits to ensure compliance with regulatory standards.
• Review and analyze test results to identify defects and drive corrective actions.
• Assist in maintaining quality documentation and technical files for regulatory submissions.
• Support the continuous improvement of quality processes within the software development lifecycle.
• Provide training and guidance to staff on best practices in software quality assurance.

Qualifications

• Bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, or a related field.
• Minimum of 3 years of experience in software quality assurance, preferably within the medical device industry.
• Strong understanding of FDA and ISO regulations relevant to medical devices.
• Proficient in software testing methodologies and tools.
• Excellent analytical and problem-solving skills.
• Strong communication skills with the ability to work collaboratively in a remote environment.
• Experience with risk management processes and quality management systems.

Technologies & Tools

The Remote Med Device Software Design Quality Engineer will utilize a variety of technologies and tools, including but not limited to software testing frameworks, defect tracking systems, risk management software, and document management systems. Proficiency in tools such as JIRA, ALM, or equivalent is essential. Familiarity with programming languages such as Python or C++ may also be beneficial to enhance test automation capabilities.

Ideal Candidates

The ideal candidate for this position will possess strong attention to detail and a deep commitment to quality and compliance within the medical device industry. They should be self-motivated, able to thrive in a remote work environment, and exhibit excellent time management skills to manage multiple priorities effectively. Furthermore, strong collaboration and interpersonal skills are crucial, as this role involves working closely with various teams to ensure the highest standards of product quality are achieved.