Senior Software Engineer - Advanced Quality
Less than 5 years experience • Medical Devices & Diagnostics
Would you like to work on exciting NEW projects that are advanced development projects for one of the world's leading medical technology companies?
Here is your opportunity to work on something truly meaningful and innovative while enjoying excellent compensation and a world-class work environment! You can be part of a team that is driven to make healthcare better by designing, developing and delivering premium products!
The Senior Level Software Quality Engineer helps the company achieve its' goal of providing the best innovative products on the market by integrating quality into the design and process during new product development. In this role, you will play a vital role in the development of new products with a global organization that is at the top of their game in the field of advanced medical devices and healthcaretechnology. In this role, you will be responsible for full cycle software development starting from planning till deployment of the software. You will also have an opportunity to train and lead a project team through Software Defect Management in all phases of development. If you have strong knowledge and hands-on experience in full cycle software development, and want to use your skills and experience to make a meaningful and positive impact in the world, then this position is an ideal role for you.
What We are Looking For:
- ---Bachelors degree or Master's degree in Computer Science, Software Engineering, Computer Engineering, Electrical Engineering, or related field or equivalent discipline (REQUIRED).
- ---Knowledge of fundamental and advanced concepts, practices and procedures in regards to software development.
- ---2+ years of experience in software test or quality is a distinct advantage.
- ---2+ years of experience in an equivalent position within an R&D environment is preferred.
- ---Experience working in a regulated industry such as Medical, Aerospace, Defense, Communication, and/or Automotive embedded software control experience is a plus.
- ---ISTQB or ASQ CSQE or equivalent experience and certification is desirable
- ---Develop software as per the SDLC with primary focus on planning, defining requirements, testing, and deployment.
- ---Co-develop software solutions by conducting research to understand user needs, data usage, systems flow, work processes, problem areas and bug reporting, and driving good code practices.
- ---Provide engineering input to impact the design, coding and debugging of software in various coding languages, including SOUP software.
- ---Perform software analysis, code analysis, requirements analysis, software review, identification of code metrics, system risk analysis, and software reliability analysis.
- ---Perform software build, maintenance, and change control.
- ---Maintain software configuration management in Perforce.
- ---Lead project team through Software Defect Management in all phases of development.
- ---Collaborate with other engineering disciplines, such as electrical, mechanical and industrial design, to ensure that embedded software will accomplish design goals for a particular product or system.
- ---Help guide New Product Development teams through the quality system to ensure software is developed in compliance with internal procedures as well as the requirements of the FDA, ISO, and other regulatory bodies, which may include: FDA, ISO 13485, ISO14971, FDA 21 CFR Part 11, FDA 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001, ANSI AAMI IEC 62304:2006 (formerly AAMI SW68), AAMI TIR32, AAMI TIR36, AAMI SW87, AAMI TIR45, IEC 80001-1, BS EN 60601-1-2: 2007, CEI IEC 60812, IEC TR 80002-1, DS DS/EN 61508-6, ISO 60601-3rd Edition and FDA General Principles of Software Validation GPSV requirements.
- ---Review and evaluate project documentation for compliance as well as sound technical competence to ensure the company is delivering robust products.
- ---Perform software risk analysis and develop risk control measures and test strategies to ensure safe and reliable products are launched to the company?s high quality standards.
- ---May have involvement in continuous improvement projects for the organization.
- ---Involvement in training others.
- ---Some travel (up to 10%).
US Citizens and Green Card holders encouraged to apply. H1B transfers ONLY. Hiring company will not consider OPT/F1.
Knowledge of the following areas may be helpful:
Quality, Software, SDLC, "software development life cycle", requirement, test, bug, debug, coding, codes, Language, Programming, SOUP, analysis, configuration, "Defect Management", "New Product Development", NPD, FDA, ISO, "Software Validation", GPSV, "General Principles of Software Validation", "Computer Science", "Computer Engineering", ISTQB, ASQ, CSQE