Senior Software QA Engineer

The Senior Software QA Engineer will be at the forefront of designing product quality into our next-generation clinical and biopharma Osmometer instruments from the start. Utilizing their experience in modern medical device development, this individual will work closely with our Regulatory Affairs / Quality Assurance and Engineering teams to develop overall test strategy for new products under development. This individual will actively propose and lead process improvements to reduce product development timelines while ensuring the quality and security of our solutions are market leading.

You will be accountable for ensuring proper test case coverage, execution, review, and traceability documentation for assigned projects.

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 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

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

Knowledge with 21 CFR Part 11 requirements

Experience testing devices to published 3rd party communication protocols and APIs

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

Nova Biomedical takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As a part of our commitment to a diverse and inclusive workforce, Nova Biomedical will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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