Software Quality Engineer
1 month ago
ABOUT INSPIRE MEDICAL SYSTEMS
Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Our focus on patient outcomes is at the core of everything we do, and our “think I can” attitude drives us to make a difference in the lives of those seeking alternative sleep apnea treatments.
WHY JOIN OUR FAST-GROWING TEAM
At Inspire, we value people – your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community. We embrace a people-first culture by offering hybrid work schedules, excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement.
If you’re passionate about making a difference in people’s lives and want to work with innovative technology, come be a part of our great team
ABOUT THIS POSITION
Software Engineer, Quality / Software Quality Engineer to 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 Inspire Medical Systems.
OPPORTUNITIES YOU WILL HAVE IN THIS ROLE
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 3 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.Preferred Qualifications
Working knowledge of software development lifecycle principles including test methods for intended use.Working knowledge of AAMI TIR 36 Validation of software for regulated processes.Automation of critical business processes and manufacturing systems.Documentation systems, authoring QMS procedures and work instructions.Working knowledge of 21 CFR Part 11 requirements for Electronic Records / Electronic Signatures.Familiar with ISO IEC 12207 Systems and software engineering – Software life cycle processes.Familiar with ISO IEC 15288 Systems and software engineering – System life cycle processes.#LI-AM1
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