Senior SQA Engineer

Position Title: Senior SQA Engineer Department: Product Development

Reports To: Principal SQA Engineer/Tech Lead FLSA: exempt

Senior SQA Engineer is a senior-level position that involves the testing and verification of complex software solutions to ensure they meet quality standards. This role identifies software defects and contributes to the delivery of high-quality products that meet the needs of the intended use of our products as well as the quality and regulatory expectations for medical device development and production.

• Participate in verification, testing, and documentation of medical device software per governing SOPs
• Document verification procedures, verification results and traceability matrices.
• Develop solid understanding of the medical device software products
• Document testing methodologies, along with defect tracking and reporting.
• Create, execute, and maintain test scripts for use within projects and regression testing.
• Set up and maintain testing environments for different testing needs
• Work closely with the software engineering team in all phases of the development cycle.
• May work on automating verification procedures to achieve test automation of the medical device software products
• Mentor more junior SQA engineers and conduct technical training for the SQA engineering team.

• Additional responsibilities may or may not be assigned to the employee; role assignment will be reviewed on a case‑by‑case basis determinant upon individual strengths, experience, knowledge, and expertise.

• 5-10 years of experience with a bachelor’s degree, 3-7 years of experience with a master’s degree, or 1-5 years of experience with a PhD degree in mathematics, computer science, engineering, or related field from a 4-year college or university.
• 3-5 years’ experience in software testing of medical device software.
• Strong understanding of test automation is a plus.
• Good testing knowledge and experience of software applications.
• Good knowledge of QA process development and testing experience with software that has a hardware component is a plus.
• A strong sense of software quality and attention to details.
• Excellent written and verbal communication skills.
• Strong analytical problem solving skills.
• Ability to mentor staff
• Ability to work successfully in various sizes of teams or independently to meet project deadlines.