It is one of the world’s leading medical technology companies and together with its customers, it is driven to make healthcare better. The Company offers a diverse array of innovative medical technologies, including orthopaedics, medical and surgical, and neurotechnology & spine products to help people lead more active and more satisfying lives. Its products and services are available in over 100 countries around the world. One of the top Fortune 100 Companies in the NYSE.
• Developing software according to SDLC with primary points of focus on planning, defining requirements, testing, and deployment.
• Co-develops 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.
• Performs software analysis, code analysis, requirements analysis, software review, identification of code metrics, system risk analysis, and software reliability analysis
• Performs Software build, Maintenance, and change control. Maintains software configuration management in Perforce.
• Lead project team through Software Defect Management in all phases of development.
• Collaboration 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 our quality system to ensure software is developed in compliance to internal procedures as well as the requirements of the FDA, ISO, and other regulatory bodies.
• Review and evaluate project documentation for compliance as well as sound technical competence to ensure we are delivering robust products.
• Perform software risk analysis and develop risk control measures and test strategies to ensure safe and reliable products are launched to Organisation's high quality standards
• BE/B.Tech/MCA/M. Tech/MS- Computers
• 5~10 years of related experience, medical device preferred.
• Demonstrated verbal and written communication skills
• Experience with: 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
Current CTC: 1.5 to 2x of experience