Software Quality Engineer

Job Summary:

The Software Quality Engineer for Medical Device is responsible for ensuring the quality, reliability, and compliance of software used in medical devices. This role involves developing and implementing software quality assurance processes, conducting rigorous testing, and collaborating with cross-functional teams to identify and resolve defects. The engineer will also ensure adherence to regulatory standards and industry best practices, perform risk analysis, and contribute to the development of risk mitigation strategies. Additionally, the engineer will address cybersecurity concerns to protect patient data and device integrity. This position requires a strong understanding of the software development life cycle, software testing methodologies, and regulatory requirements specific to medical devices. The ideal candidate will possess excellent problem-solving skills, attention to detail, and the ability to work effectively in a team environment.

Duties & Responsibilities:

• Support the Product Assurance goal of driving making quality a competitive advantage;
• Ensure compliance with Quality System Regulations (FDA CFR 21 820), ISO 13485, Canadian Medical Device Requirements (CMDR), MDD 93/42 EEC and other applicable international medical device standards and regulations;
• Perform other duties or special projects as requested.
• Review software design requirements and testing protocols
• Participate in software design reviews.
• Review test reports including integration, system, and acceptance testing.
• Develop and implement risk management plans to mitigate identified risks.
• Perform risk analysis to identify potential hazards associated with software used in medical devices.
• Collaborate with cross-functional teams to ensure risk controls are effectively integrated into the software development process.
• Monitor and review risk management activities to ensure ongoing compliance with regulatory requirements.
• Monitor and analyze post-market data to identify software-related issues to collaborate with software development teams to resolve issues.
• Develop and maintain Design History Files (DHF) for products;

Minimum Qualifications:

• 3 years of Quality Engineering/Quality Assurance experience;
• Minimum of 3 years of experience in software quality assurance, preferably in the medical device industry.
• Strong knowledge of software development life cycle (SDLC) and software testing methodologies.
• Familiarity with regulatory requirements for medical device software (e.g., FDA 21 CFR Part 820, ISO 13485).
• Experience with software validation and verification processes.
• Excellent problem-solving skills and attention to detail.
• Strong communication and interpersonal skills.
• Ability to work effectively in a team environment.
• Strong communication, documentation, problem solving and teamwork skills;
• Proficiency with Microsoft Office applications;

Preferred Qualifications:

• Certified Quality Engineer (CQE)

Education:

• B.S. in Computer Science, Software Engineering, Electrical Engineering, Biomedical/Biomechanical Engineering, or a related science/engineering discipline is required.
• M.S. in a related Engineering or science discipline is a plus.

Compensation: The anticipated range for this position is $70,000 - $100,000. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience. This position also qualifies for up to 10% annual bonus based on Company, department, and individual performance.

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver's license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.