ABOUT THE JOB

Visby Medical is seeking a highly skilled and detail-oriented Software Quality Engineer to join our dynamic team. The ideal candidate will have a proven track record of ensuring high-quality software releases within a regulated environment, possess excellent organizational and time management skills, and demonstrate experience in collaborating with external software development companies. This role requires a strong understanding of software development processes, regulatory requirements, and the ability to effectively coordinate and communicate with external partners to ensure successful project outcomes.

HOW YOU’LL MAKE AN IMPACT

• Develop and execute test plans, test cases, and test scripts to validate software functionality and performance.
• Identify and document software defects, working closely with software engineers to facilitate timely resolution.
• Stay current with relevant software lifecycle and cybersecurity standards and guidance documents and develop policies and procedures to ensure compliance.
• Collaborate with internal and external software development stakeholders to ensure comprehensive and compliant software documentation, including but not limited to Software Design Specifications (SDS), Software Requirements Specifications (SRS), Software Development Plans (SDP) and architecture documents.
• Collaborate with external software development partners, internal teams, product managers, and regulatory stakeholders to gather information and ensure accurate and up-to-date documentation.
• Review and approve software lifecycle documents to ensure compliance with Visby’s policies and procedures and relevant standards and guidance documents.
• Assist in the preparation and submission of regulatory documentation, including 510(k)s and technical files, including authoring the software sections of regulatory submissions.
  
  

ON YOUR FIRST DAY WE’D LIKE YOU TO HAVE

• Bachelor's degree in Computer Science, Engineering, or a related field.
• 3-5 years proven experience in software documentation and quality assurance in the medical device industry or a similarly regulated environment.
• Strong understanding of software development processes, including Agile methodologies.
• Experience working with external software development companies for software development projects.
• Excellent written and verbal communication skills, with the ability to convey technical information in a clear and concise manner.
• Meticulous attention to detail and exceptional organizational skills.
• Proficiency in using documentation tools, version control systems, and issue tracking software.
• Ability to work independently and collaboratively in a fast-paced, deadline-driven environment.
• Proven track record of meeting deadlines and delivering high-quality work.
• Demonstrated understanding of cybersecurity requirements for medical devices.

IT’S GREAT IF YOU HAVE

• Familiarity with relevant regulatory standards and guidelines, such as FDA 21 CFR Part 820, ISO 13485, IEC 62304.

MORE ABOUT THE TEAM

• Join our team and contribute to the development of cutting-edge medical device software that improves patient outcomes and enhances healthcare delivery.

SALARY RANGE:

• $110,000 - $130,000 (Minimum to maximum salary range for candidates based in San Jose, CA)
• Compensation for the role is based on geographical location.
• Compensation also depends on a number of factors including a candidate’s qualifications, skills, competencies and experience and may fall outside of the range shown.