This individual will apply software Quality Assurance principles in the development, specification, configuration, validation, and implementation of software applications and automated systems per the applicable software lifecycle within the organization.

Company Profile

Client is a smaller medical device company that’s developed the world’s first fully implanted neurostimulation device for the treatment of obstructive sleep apnea.

Primary Responsibilities:

• Provides leadership in coordinating software development lifecycle activities and works under minimum supervision.
• Collaborates with team members to derive and document user and software requirements needed to develop software solutions.
• Authors software deliverables per procedures related to software development lifecycle and testing for regulated systems.
• Applies knowledge of software V&V methods for risk mitigation, sound software engineering, and formal validation process.
• Develops and executes software test protocols and interprets/analyzes results. May involve application of test tools for manual/automated test cases.
• Utilizes end user and business process workflow scenarios for reference while developing software test protocols.
• Conduct Traceability Analysis to show requirement to test case mapping and ensure comprehensive test coverage.
• Other QA/QS duties as assigned.

Required Qualifications:

• BA/BS or 2-Year Certificate in Software Engineering, Computer Technology, Software Quality, or similar degree with related coursework.
• Minimum of 10 years developing and executing software test protocols for corporate applications within the medical device or pharma industries.
• Excellent technical writing skills for software deliverables, such as Validation Plans, Test Protocols, and Reports.
• Strong analytical, prioritization, organizational and problem-solving skills.
• Strong communication and documentation skills.
• Strong emphasis on process and details.

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