Our client located in Cambridge, MA is looking for a Principal Software Quality Engineer to join their team as they develop a first-generation, revolutionary medical device aimed at improving patients’ quality of life. This Software Quality Engineer will take the lead of all testing, validation, verification, and software regulatory compliance.

Responsibilities

• Plan, schedule and lead cross-functional teams in COTS/SOUP software quality, medical device product software, and manufacturing instrument software quality. Work in close partnership with the Product Development and Manufacturing team leaders. Create and maintain the Master Validation Plan, and define level of validation for IT infrastructure systems, equipment, SOUP/COTS and product software. Responsible for the software quality.
• Plan, facilitate and implement software validation projects using cross-functional teams. Develop software quality strategies in conjunction with the project team in the manufacturing plants and Product Development Engineering. Identify and resolve team technical capacity and resource issues.
• A successful candidate will be willing to develop and prioritize plans broadly for the organization but also be willing to participate in execution of software validations.

Requirements:

• Minimum of three years in medical device Software Quality including medical device product software, SOUP/COTS validations and equipment validations. Experience in cloud based software validations a plus.
• Experience with medical device regulations
• Bachelor’s degree in Engineering, Computer Science, or related discipline required.
• Languages: C++, Python
• Experience writing and executing automated test suites. Experience with GTEST testing framework a plus.
• Familiarity with static analysis and code coverage tools.
• Familiarity with behavior driven development (Cucumber, Behave, SpecFlow) a plus.

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