Software Quality Engineer

Associate          ·        Austin, Texas Metropolitan Area (On-site)           ·         Full time

About the job

The Role

The Software Quality Engineer will directly support the quality assurance and compliance activities for the software development aspects of the Connexus system. This includes software considerations for firmware, programmable logic, Software in a Medical Device (SiMD), Software as a Medical Device (SaMD), and Artificial Intelligence/Machine Learning (AI/ML) software. This role will provide hands-on support throughout the software development, verification, and validation process including risk management and security controls. The Software Quality Engineer will collaborate extensively with Software Development, Product Development, Quality, and Regulatory Affairs to ensure the design control elements are established and fulfilled during the phase-gated design process, and applicable standards and regulations pertaining to medical device software are adequately addressed. This role will lead quality software development and verification activities and directly support software testing automation efforts. This role will also be engaged in cybersecurity efforts and ensure the cybersecurity information required to support regulatory submissions is adequately planned and completed.

This position is instrumental in supporting the company’s continued growth and future success and requires an individual with a “can-do,” self-starter attitude who is excited about working collaboratively and diving into hands-on, detailed work in an early-stage medical device company. This individual must be able to step back to view the bigger picture and understand where we are as a company to set priorities, strategy, and direction. This position is based on-site in Austin, Texas, and will have less than 5% travel.

Responsibilities include:

• Work closely with the software development team to ensure that software requirements are well-defined, testable, and verifiable.
• Develop and maintain software documentation in accordance with regulatory requirements for a Class III medical device, such as software requirements specifications, software design documents, software testing plans, and software risk management documentation.
• Develop and execute test plans and protocols to validate software functionality and performance in accordance with applicable regulatory standards, including IEC 62304 and 21 CFR 820.30.
• Perform security and threat modeling of the software to identify potential security risks and develop security controls to mitigate these risks.
• Conduct and document risk assessments to identify potential hazards associated with the software and develop risk mitigation strategies.
• Collaborate with cross-functional teams, including hardware engineers, clinical personnel, and quality assurance personnel, to ensure that software is integrated and tested properly within the overall medical device system.
• Support the preparation and submission of regulatory documents related to software validation and verification, including the software documentation required for a Class III medical device.
• Provide technical support for regulatory submissions, including responding to regulatory agency inquiries and supporting audit and inspection activities.
• Manage software configuration control, including the tracking of software changes, version control, and change impact analysis.
• Provide training and support to software development and quality assurance personnel on software validation and verification processes and regulatory requirements.
• Participate in internal and external audits, as needed.

Required Qualifications

• Bachelor’s degree in software engineering, software development, or related technical field.
• 5+ years of software quality engineering experience or software development experience in the medical device field.
• Experience with medical device quality standards and regulations relating to medical device software including cybersecurity. Working knowledge of applicable standards including IEC 62304 and FDA guidance documents for software and cybersecurity.
• Experience as a core team member with hands-on responsibilities supporting the software development life cycle and cybersecurity considerations.
• Demonstrated knowledge of the software quality engineering processes in the medical device industry and the related documentation requirements.
• Experience with the software verification process and requirements, including experience investigating verification discrepancies and creating best practices and workflows to optimize testing and change management efforts.
• Experience supporting internal and external audits.
• Demonstrated ability to develop creative solutions to complex problems that meet quality and regulatory requirements and business needs, while sharing knowledge and building consensus amongst stakeholders.
• Demonstrated ability to thrive in a team environment with a diverse group of people, where individual contributions are highly valued.
• Demonstrated ability for continuous learning and improvement.
• Excellent communication skills both orally and in written form with a desire for in-person communication. This includes experience leading meetings, projects, and presentations to small and large audiences.
• Excellent organizational skills and the ability to manage competing priorities and plan accordingly.
• Proficient with version control using Git, as well as associated tools like Github, Gitlab, etc.
• Experience with multiple programming languages such as Python, JavaScript, TypeScript, Rust, and C.
• Proficient skills with Microsoft Office Suite, Google G-Suite, and other PC-based systems.
• Experience with medical device quality standards and regulations (FDA 21 CFR 820, ISO 13485, ISO 14708, ISO 14971).

Preferred Qualifications

• Experience with machine learning tools such as TensorFlow or PyTorch.
• Experience in the field of FDA Class III medical devices, including active implantable devices.
• Experience directly supporting FDA regulatory submissions such as Q-subs, IDE, PMA, 510(k). Regulatory submissions outside of the U.S. will also be considered.
• Experience working with brain-computer interfaces, deep brain stimulation, or other neurostimulation/neuromodulation medical devices.

Paradromics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.

Please click here to apply.