Design Quality Engineer (Medical Device Software)

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 Advanced Clinical, so some details may not match this job. The employer's own page has the real description.

Overview

As a Design Quality Engineer specializing in Medical Device Software at Advanced Clinical, you will play a crucial role in ensuring that our software products meet rigorous quality and regulatory standards. Your primary responsibilities will involve collaborating with cross-functional teams to define and implement design controls throughout the product lifecycle, conducting risk assessments, and leading quality assurance activities. By employing your solid understanding of software verification and validation processes, you will help uphold the safety, efficacy, and compliance of our medical devices, ultimately contributing to the well-being of patients and healthcare providers.

Job Responsibilities

• Develop and implement design quality plans in accordance with regulatory requirements and company policies.
• Conduct risk management activities including hazard analysis and failure mode effects analysis (FMEA).
• Collaborate with product design and development teams to establish and maintain design control documentation.
• Perform independent software verification and validation (V&V), ensuring adherence to validation protocols.
• Evaluate software design outputs for compliance with specified design requirements.
• Facilitate and participate in design reviews, providing feedback on quality metrics and processes.
• Assist in the investigation of non-conformances and implement corrective and preventive actions (CAPA).
• Prepare and maintain documentation for regulatory submissions and audits.
• Support the training of team members on quality assurance and regulatory compliance processes.
• Stay current with industry standards and best practices in software quality assurance and regulatory requirements.

Qualifications

• Bachelor's degree in Engineering, Computer Science, or a related field; a master’s degree is preferred.
• A minimum of 3 years of experience in design quality engineering related to medical device software.
• Extensive knowledge of FDA regulations, ISO 13485 standards, and the medical device product development lifecycle.
• Proficiency in software QA methodologies, tools, and processes, including V&V documentation.
• Strong analytical skills with the ability to conduct thorough risk assessments and problem-solving activities.
• Excellent written and verbal communication skills, with the ability to convey complex information effectively.
• Experience in leading cross-functional teams and projects successfully.
• Certifications such as Certified Quality Engineer (CQE) or Certified Quality Improvement Associate (CQIA) are a plus.

Technologies & Tools

The Design Quality Engineer will use a variety of technologies and tools, including software validation tools, risk management software, design control management systems, and electronic document management systems. Familiarity with programming languages such as Python or Java may be beneficial for understanding software development processes. Additionally, knowledge in using tools like JIRA, MATLAB, and other engineering software solutions will enhance efficiency in quality assurance activities.

Ideal Candidates

Ideal candidates for the Design Quality Engineer position will possess a keen attention to detail and a proactive approach to problem-solving. They should demonstrate a strong commitment to maintaining high-quality standards and are able to navigate the complexities of regulatory environments. Successful individuals in this role will also show excellent interpersonal skills and the ability to work collaboratively with diverse teams. Passionate about improving patient outcomes and adhering to best practices in medical device software, they will embody a results-driven mindset with an unwavering dedication to excellence.