Software Quality Assurance Engineer - Medical Device

Software Quality Assurance Engineer - Medical Device

We are seeking a dedicated Quality Assurance Engineer with expertise in Medical Device Software Applications and medical device software regulations to join our dynamic team. If you have the right skill set coming out of another regulated manufacturing industry, such as aerospace, rail, or automobile, we will consider you.

This role is critical in ensuring our medical devices meet stringent industry standards and regulatory requirements. The successful candidate will possess a strong background in software engineering, with specific skills in embedded, cloud, and mobile applications. Experience with continuous integration and continuous delivery (CI/CD) processes is also essential. This position requires meticulous attention to detail and a strong commitment to ensuring software reliability and compliance with the 510(k) submissions for class 2 medical devices.

• Oversee and manage the entire lifecycle of bug tracking and verification documentation for feature enhancements from detection through resolution and validation, ensuring all changes are properly documented and traceable to specific requirements in the design matrix.
• Collaborate with development teams to ensure thorough investigation, accurate fixes, and robust testing of software issues.
• Write, execute, and document comprehensive test plans for validation and verification of software functionalities to ensure compliance with US and international standards and guidance.
• Review design input verification entrance criteria, i.e., results of code reviews, unit test and static analysis to ensure compliance and communication between development and test teams.
• Integrate and maintain CI/CD pipelines for automated testing to improve the efficiency and effectiveness of the development cycle.
• Participate in the development and review of system and product requirements to ensure testability and traceability in compliance with medical device regulations, standards and guidance.
• Provide technical guidance and support to other team members regarding best practices in software quality assurance.
• Maintain up-to-date knowledge of regulatory standards affecting software quality assurance in the medical devices field. Standards include but are not limited to:
• FDA 21 CFR Part 820 for quality system regulations
• FDA Software Validation Guidance
• FDA Software Development Guidance
• IEC 62304 for medical device software life cycle processes
• ISO
  13485 for medical device quality management systems
• ISO 14971 for risk management

• Bachelor’s degree in Computer Science, Electrical Engineering, related field or equivalent experience.
• Minimum of 3 years experience of full-time permanent work experience after graduation from college in QA for embedded systems, ONLY in the medical device or similarly regulated manufacturing industry such as air, rail or auto.
• Profound knowledge of Linux operating systems and kernel-level testing.
• Experience with one or more CI/CD and/or CI/CT tools and practices.
• Strong skills in Python or related programming language for use in automated test development.
• Familiarity with regulatory standards and documentation requirements specific to class II medical devices and FDA 510(k) submissions.
• Excellent analytical, problem-solving, and communication skills.

• Certification in Quality Assurance or Software Testing.
• Internal Audit Certification.

Salary range: $110,000–$120,000 + 10% Bonus

My client would prefer to hire a local candidate already living in the Buffalo/Rochester, NY area. Will consider someone who is from Western New York and would like to return.

Associate

Full-time

Engineering and Quality Assurance

Industries

Medical Equipment Manufacturing

• Medical insurance
• Vision insurance
• Tuition assistance
• Disability insurance
• 401(k)

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