Senior Software QA Engineer

About the role

The Senior Software QA Engineer will be responsible for designing product quality into the development of Nova Biomedical's next-generation clinical and biopharma Osmometer instruments. They will collaborate with Regulatory Affairs / Quality Assurance and Engineering teams to develop overall test strategies for new products under development.

Responsibilities

• Lead the development, review, and execution of software quality assurance processes and procedures for assigned projects
• Collaborate with cross-functional teams to ensure software development and validation activities meet quality and compliance requirements
• Perform risk assessments and develop mitigation strategies for software-related issues
• Conduct software validation activities in accordance with regulatory standards (FDA, ISO 13485)
• Review and approve software documentation, including validation plans, protocols, and reports
• Participate in internal and external quality audits
• Monitor and analyze software quality metrics to identify trends and areas for improvement
• Provide training and support to team members on software quality and validation processes
• Implement process and tool improvements to bring verification test case writing and approval concurrent with development for iterative development cycles
• Actively participate as a member of the development team, including reviewing work item acceptance criteria, providing inputs into work item estimation, and reporting of test status
• Execute manual and automated test cases for verification of requirements and work items within a development iteration

Requirements

• Proven track record of commercial software test engineering in a medical device, scientific instrument, or similar environment controlling hardware as part of an overall system
• Bachelor's degree or higher in a relevant computer science, engineering subject, or equivalent commercial software engineering experience
• Commercial experience testing and shipping medical devices under ISO 13485
• Familiarity with current FDA requirements and guidance for cybersecurity
• Familiarity with feature, regression, and integration testing
• Experience utilizing Azure DevOps or similar systems for backlog, sprint boards, and test case management
• Understanding and practice of working in, and testing solutions for, regulatory compliant environments
• Skills in setup and configuration of PC, server, cloud hosted, and hardware test environments
• Understanding and experience with both business-oriented Agile and waterfall software development lifecycles
• Experience testing devices to published 3rd party communication protocols and APIs

Physical Requirements

• Ability to work at a computer for extended periods
• Ability to lift and carry up to [25–50] pounds as required
• Ability to communicate effectively via phone, video, and written communication
• Ability to occasionally move about the office to access meetings or resources

Benefits

• Flexible Medical, Dental, & Vision Coverage
• Competitive 401k company match
• Bonus Program, Generous PTO and paid holidays
• Generous Tuition reimbursement
• Hybrid and flexible work arrangements
• Professional development, engagement and events
• Company marketplace for lunch and snacks in our Norwood, MA, Billerica, MA and Westbrook, ME offices
• Company subsidized cafeteria in our Waltham, MA office

Pay

Targeted Salary Range: $120,000- $130,000/year

Schedule

Hybrid work schedule on-site in Norwood, 4 days/week on-site