Design Quality Engineer (Medical Device Software)

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Job Overview

The Design Quality Engineer (Medical Device Software) at Advanced Clinical is a pivotal role that combines engineering principles with quality assurance practices. The incumbent will be responsible for ensuring that medical device software meets established regulatory standards and design specifications throughout the product lifecycle. This includes conducting reviews, risk assessments, and validation activities to maintain compliance and ensure that the software is both safe and effective for intended use. The Design Quality Engineer will collaborate with cross-functional teams to enhance product quality and reliability while facilitating continuous improvement initiatives.

Job Responsibilities

• Develop, implement, and maintain quality assurance protocols and processes for software in medical devices.
• Conduct design reviews and risk assessments to identify potential failures and ensure compliance with relevant regulatory standards.
• Collaborate with software development teams to integrate quality management practices into the software development lifecycle.
• Perform validation and verification activities, ensuring that software functionalities meet design specifications and user needs.
• Facilitate root cause analysis and corrective action processes for quality-related issues.
• Prepare and maintain documentation associated with quality assurance activities, including test plans, reports, and compliance records.
• Provide training and support to team members regarding quality assurance methodologies and compliance requirements.
• Assist in preparing submissions for regulatory bodies, including FDA and other relevant entities.

Qualifications

• Bachelor's degree in Engineering, Computer Science, or a related field.
• Minimum of 3 years of experience in quality assurance or design quality engineering, particularly within the medical device industry.
• Strong knowledge of regulatory standards such as ISO 13485, FDA 21 CFR Part 820, and IEC 62304.
• Proficiency in software life cycle processes, risk management, and validation methodologies.
• Excellent problem-solving skills and attention to detail.
• Experience with quality management systems and related software tools.
• Effective communication skills, both verbal and written, with the ability to work collaboratively within teams.

Technologies & Tools

The Design Quality Engineer will utilize a variety of technologies and tools, including quality management software (e.g., MasterControl, TrackWise), risk management tools (e.g., FMEA software), as well as programming languages (e.g., Python, C++) for software verification. Familiarity with automated testing tools and software development environments will be beneficial to effectively assess and validate medical device software.

Ideal Candidates

Ideal candidates for this position should possess a proactive and results-oriented mindset, with a strong commitment to delivering high-quality medical device software. They should demonstrate exceptional analytical thinking and problem-solving abilities, coupled with a collaborative spirit to work effectively in cross-functional teams. Strong communication skills are essential to articulate quality assurance practices and findings clearly. A passion for innovation and continuous improvement in the medical technology domain will further enhance the candidate's suitability for this role.