Job
Description
We are actively seeking exceptional candidates to join one of the largest medical device company globally, recognized as a leader in medical, scientific, and imaging technology products. This presents an excellent opportunity to become a part of the Core R&D team in Hyderabad, focusing on New Product Development (NPD) Programs. If you believe you are a suitable candidate, please submit your most recent resume. The job description is provided below for your reference. Person Specification: Education A degree or higher qualification in Biomedical / System Engineering from a recognized university. Masters in biomedical /system engineering will be an added advantage. Experience 4-12 years of experience in System Engineering R&D in the medical devices domain, with a mix of technical and managerial responsibilities Proven experience in collaborating with PMOs and global teams on system projects Strong technical background in system design, circuit board development, and compliance with regulatory standards Experience in medical device development is preferred Skills Strong technical expertise in systems engineering, systems modeling, and requirements management, with hands-on experience in R&D and/or sustaining engineering, especially in product development environments Expertise in systems engineering methodologies, including requirements management, risk analysis, and system integration Familiarity with medical device product lifecycle management, with experience in applying FDA Design Controls and international standards (e.g., 820-CFR, ISO14971, IEC60601), ensuring compliance with project-specific regulations Experience with model-based systems engineering (MBSE) tools and methodologies Comfortable working in Agile SCRUM and stage-gate environments, ensuring collaboration with cross-functional teams to meet project objectives Ability to develop and contribute to design documentation, including requirements specifications, risk management files, and compliance records for manufacturability and quality assurance Knowledge of systems integration and architecture, contributing to design solutions to mitigate risks Understanding of software lifecycle management (e.g., EN62304) and experience with managing system-level risks and verification Experience with requirements management systems (e.g., DOORS, JAMA), contributing to risk analysis and DFMEA processes in system R&D projects Effective stakeholder management skills, collaborating with PMO teams to ensure technical alignment and timely project delivery Experience working with project data, contributing to technical assessments and identifying opportunities for process improvements and operational efficiency Strong communication skills, with the ability to present technical updates and information clearly to cross-functional teams and stakeholders
