Senior Software QA Engineer

Senior Software QA EngineerThe 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.What you'll do:Lead the development, review, and execution of software quality assurance processes and procedures for assigned projectsCollaborate with cross-functional teams to ensure software development and validation activities meet quality and compliance requirementsPerform risk assessments and develop mitigation strategies for software-related issuesConduct software validation activities in accordance with regulatory standards (FDA, ISO 13485)Review and approve software documentation, including validation plans, protocols, and reportsParticipate in internal and external quality auditsMonitor and analyze software quality metrics to identify trends and areas for improvementProvide training and support to team members on software quality and validation processesImplement process and tool improvements to bring verification test case writing and approval concurrent with development for iterative development cyclesActively participate as a member the development team, including reviewing work item acceptance criteria, providing inputs into work item estimation, and reporting of test statusExecute manual and automated test cases for verification of requirements and work items within a development iterationWhat we are looking for in you:Proven track record of commercial software test engineering in a medical device, scientific instrument, or similar environment controlling hardware as part of an overall systemBachelor's degree or higher in a relevant computer science, engineering subject, or equivalent commercial software engineering experienceCommercial experience testing and shipping medical devices under ISO 13485Familiarity with current FDA requirements and guidance for cybersecurityFamiliarity with feature, regression, and integration testingExperience utilizing Azure DevOps or similar systems for backlog, sprint boards, and test case managementUnderstanding and practice of working in, and testing solutions for, regulatory compliant environmentsSkills in Setup and configuration of PC, server, cloud hosted, and hardware test environmentsUnderstanding and experience with both business-oriented Agile and waterfall software development lifecyclesKnowledge with 21 CFR Part 11 requirementsExperience testing devices to published 3rd party communication protocols and APIsPhysical Requirements for this role include:Ability to work at a computer for extended periods.Ability to lift and carry up to [25–50] pounds as requiredAbility to communicate effectively via phone, video, and written communication.Ability to occasionally move about the office to access meetings or resources.Why work for Nova Biomedical:Flexible Medical, Dental, & Vision CoverageCompetitive 401k company matchBonus Program, Generous PTO and paid holidaysGenerous Tuition reimbursementHybrid and flexible work arrangementsProfessional development, engagement and eventsCompany marketplace for lunch and snacks in our Norwood, MA, Billerica, MA and Westbrook, ME officesCompany subsidized cafeteria in our Waltham, MA officeWork Location: Hybrid work schedule on-site in Norwood, 4 days/week on-siteTargeted Salary Range: $120,000- $130,000/yearNova Biomedical believes in transparency and integrity throughout all we do, including compensation. The provided salary range for this role represents the expected base salary or hourly rate for this opening. Actual compensation will be commensurate with the candidate's experience and may vary based on individual factors such as location, skills, and education.EEO Statement: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.