Medical Device Software Quality Engineer

About the role

As a , you will play a pivotal role in ensuring that our medical software products meet the highest standards of quality and compliance. Your expertise will contribute to the development and maintenance of software that is not only innovative but also safe and effective for end-users. You will collaborate closely with cross-functional teams, including software developers, regulatory affairs, and product management, to ensure that quality is integrated throughout the software development lifecycle. This position offers a unique opportunity to work in a dynamic environment where your contributions directly impact patient care and safety.

Key facts

What you'll do

• Develop and implement quality assurance processes for software development in compliance with relevant medical device regulations and standards, such as ISO 13485 and IEC 62304.
• Conduct thorough software testing, including functional, regression, and performance testing, to identify and resolve defects before product release.
• Collaborate with software engineering teams to define quality metrics and ensure adherence to best practices in coding and testing.
• Participate in risk management activities, including hazard analysis and risk assessments, to identify potential issues and mitigate risks associated with software products.
• Review and approve software design and development documentation, ensuring that all materials meet regulatory requirements and internal quality standards.
• Facilitate internal and external audits related to software quality, preparing necessary documentation and addressing any findings or non-conformities.
• Provide training and support to team members on quality assurance processes and tools, fostering a culture of quality within the organization.
• Utilize automated testing tools and frameworks to enhance testing efficiency and coverage, ensuring robust validation of software functionalities.
• Monitor industry trends and regulatory changes related to medical device software, adapting quality practices as necessary to maintain compliance.
• Assist in the preparation of regulatory submissions and documentation for product approvals, ensuring that all quality-related aspects are accurately represented.
• Collaborate with customer support teams to address software-related issues and gather feedback for continuous improvement.
• Participate in product development meetings to provide insights on quality considerations and ensure alignment with project goals.

Requirements

• Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field.
• A minimum of 3 years of experience in software quality assurance, specifically within the medical device industry.
• Strong understanding of software development methodologies, including Agile and Waterfall.
• Familiarity with regulatory requirements for medical devices, particularly ISO 13485, IEC 62304, and FDA guidelines.
• Proven experience in software testing, including the use of automated testing tools and frameworks.
• Excellent problem-solving skills and attention to detail, with a commitment to delivering high-quality products.
• Strong communication skills, both written and verbal, with the ability to work collaboratively in a team environment.
• Experience with risk management processes and tools related to software development.
• Proficiency in programming languages such as C++, C#, or Python is a plus.

Nice to have

• Certification in Quality Assurance or Quality Management Systems (e.g., ASQ, CQE, or similar).
• Experience with electronic health records (EHR) or other healthcare software systems.
• Knowledge of cybersecurity principles and practices as they relate to medical devices.
• Familiarity with cloud-based software development and deployment practices.

Skills & tools

• Proficient in software testing tools such as Selenium, JUnit, or TestRail.
• Experience with version control systems, particularly Git.
• Familiarity with project management tools like JIRA or Trello.
• Knowledge of continuous integration and continuous deployment (CI/CD) practices.

Practical notes

• The specific location for this role is currently unspecified, but it may involve remote work or relocation.
• The salary for this position is competitive and will be determined based on the candidate's experience and qualifications.
• Visa sponsorship may be available for qualified candidates, making this an attractive opportunity for international applicants.

META

Company: Deciphex

Title: Medical Device Software Quality Engineer

Listed

location: Unknown

Job type: Full-time

Apply URL: https://deciphex.bamboohr.com/careers/381

Tags: Engineering