Sr. Software Engineer - Advanced Quality
Job Summary of the Sr. Software Engineer - Advanced Quality:
Sr. Level Software Quality Engineer is required to play a vital role in the development of new products by integrating quality into the design and process for one of our clients in in Michigan area. This client is a global player in the field of advanced medical devices and healthcare technology. In this role you will be responsible for full cycle software development starting from planning till deployment of the software. You wail also have an opportunity to train and lead a project team through Software Defect Management in all phases of development. If you come along with strong knowledge and hands on experience in full cycle software development then this position is well suited to you.
Responsibilities of the Sr. Software Engineer - Advanced Quality:
- Develop software as per the SDLC with focus on planning, defining requirements, testing, and deployment.
- Analyse customer needs, data usage, system flow, processes, and bug reports to develops the software solutions.
- Provide support in design, coding and debugging of software in different languages including SOUP software
- Perform software, code and requirements analysis, review the software and identify the code metrics.
- Do the system risk and software reliability analysis
- Work on Software build, Maintenance, and change control and maintain software configuration management in Perforce.
- Guide and train project team through all the phases of software development and defect management.
- Ensure the achievement of design goals by working with the cross functional disciplines such as electrical, mechanical and industrial design.
- Guide and support the NPD team in quality systems to ensure the compliance with internal procedures as well as the requirements of the FDA and ISO.
- Ensure compliance with regulatory bodies including 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 and technical competence to ensure the delivery of robust products.
- Launching of safe and reliable products by developing risk control measures and test strategies.
- Work on the continuous improvement projects of the organization
Qualifications of the Sr. Software Engineer - Advanced Quality:
- Bachelors degree in CS or Software/Computer/Electrical Engineer, Masters preferred
- Knowledge of fundamental and advanced concepts, practices and procedures in regards to the software development.
- ISTQB or ASQ CSQE or equivalent experience and certification is desirable
- 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 will be preferred
- Experience with regulated industries such as Medical, Aerospace, Defense, Communication, and automotive embedded software control will be a plus.
Compensation of the Sr. Software Engineer - Advanced Quality:
Salary Range: $70000-$107000year, depending on experience
Location: Stevensville, MI
Travel: As required (Up to 10%)
Relocation Assistance: Yes
Visa Sponsorship: H1B transfers only. NO OPT/F1 will be considered
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
Role: Sr. Software Engineer - Advanced Quality
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