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.

What You Will Do

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.

Why It Might Be a Fit

We are looking for a 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. Familiarity with current FDA requirements and guidance for cybersecurity is also required.

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
• Knowledge with 21 CFR Part 11 requirements
• Experience testing devices to published 3rd party communication protocols and APIs

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