Senior Software Engineer- Java

Quest Global is an organization at the forefront of innovation and one of the world’s fastest growing engineering services firms with deep domain knowledge and recognized expertise in the top OEMs across seven industries. We are a twenty-five-year-old company on a journey to becoming a centenary one, driven by aspiration, hunger and humility. We are looking for humble geniuses, who believe that engineering has the potential to make the impossible, possible; innovators, who are not only inspired by technology and innovation, but also perpetually driven to design, develop, and test as a trusted partner for Fortune 500 customers. As a team of remarkably diverse engineers, we recognize that what we are really engineering is a brighter future for us all. If you want to contribute to meaningful work and be part of an organization that truly believes when you win, we all win, and when you fail, we all learn, then we’re eager to hear from you. The achievers and courageous challenge-crushers we seek, have the following characteristics and skills:  Roles & Responsibilities: Systems Engineer with 4-8 Years of experience in medical device domain Strong hold on process knowledge of the Medical Device Lifecyle (all phases) Identify and define internal and external customer needs/requirements for product or solution with thorough knowledge of system and product understanding. Regulatory knowledge – IEC 60601-1, ISO 13485, ISO 14971, etc. Software development lifecycle as per IEC 62304 Understands the Software interactions with device. Have experience in Class II or Class III medical device. Experience in working in Cloud based environment. Co-ordinate with internal and external stakeholders to understand the requirements and clarity on the complete scope of changes & impacts. Understanding the region-specific requirements and need to work collaboratively with R&D and cross functions for program delivery. Provide system support to the development team to ensure that the project successfully meets the schedule & quality aspects throughout the project life cycle. Excels in the creation of system use Cases for product or solution based on the regional demands, customers, and their local environments. Use tools such as DOORS and excels in the management of requirements and decomposition of system level requirements to modules. Ensure detailed, high quality technical documentation to capture and communicate product changes and configurations with the necessary stakeholders. Actively engage with development team and other system engineers to aid in the overall integration of product changes. Ensure timely delivery of features and tasks with high quality. Working independently or under the guidance of senior staff. Required Skills (Technical Competency): Experience in Medical Device development, FDA Regulations and MDR. Exposure to Usability Engineering Process Experience in regional language configurations & expansions. Strong interpersonal skills with the ability to collaborate with others in a team environment. Understanding of and adherence to FDA, ISO and IEC design control procedures, regulations and standards. Demonstrated experience in accomplishing objectives. Able to deliver on multiple projects simultaneously. Self-motivated with good interpersonal and communication skills. Desired Skills: The role of System Engineer is to contribute in sustainable and development of a product or solution to the market, from understanding the needs of the product across regions & countries to the validation of the product changes to the regions. You will apply system knowledge and engineering principles in catering to the needs of the market and solutions specific to the regions. This position is based out of Bangalore and reporting to the Systems Manager.