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Posted 8 months ago
Requirements and responsibilities
Job Location - Hyderabad
Work Experience - 17+ years
Responsibilities may include the following and other duties may be assigned.
• Collaborate with stakeholders to translate requirements into platform solutions and evaluate emerging technologies.
• Design, develop, test, document software components, and resolve infrastructure/application issues.
• Lead CAPA, field investigations, and capacity planning for platform growth.
• Maintain technical documentation and drive continuous improvement with Agile/Scrum.
• Interface with cross-functional teams, ensuring compliance with standards and regulations.
• Report to the Engineering Director and collaborate with global teams, vendors, and stakeholders.
• Assess design changes, applying Model-Based Systems Engineering and ensuring safety and risk management compliance.
• Mentor junior engineers, track deliverables, and support occasional travel.
TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.
Must Have:
• B-Tech/BE in Computer Science/Electronics or equivalent with 17+ years of relevant experience
• ME/M-Tech in Computer Science/Electronics or equivalent with 15+ years of relevant experience.
Skills & Experience
Industry Experience & Domain Knowledge
• Experience in the Medical Device Industry or related field.
• Experience in regulated environments and global regulatory compliance.
• Prior experience with FDA Class I, II, and III Medical Device systems.
• Understanding of complex embedded systems and software.
• Familiarity with networking protocols.
Technical Expertise
• Expertise in Embedded C/C++ within RTOS development environments.
• Hands-on experience in Embedded/Firmware Device Drivers.
• Proficient in hardware/software interfacing and design.
• Desired experience with Qt, SQLite, Linux Yocto, and Security.
• Strong understanding of software development and system design.
Software Development Practices
• Proficiency in Agile software development processes.
• Experience with change control, requirements management, and source code control.
• Conduct Code Reviews, Static and Dynamic Code Analysis.
• Generate software metrics for Unit and Integration Testing.
Team Collaboration & Communication
• Strong interpersonal, presentation, and organizational skills.
• Ability to work in flexible settings and different time zones.
• Ability to work in a team environment and directly contribute to its success.
• Participate in system design and coordinate with teams and internal product management.
• Leadership and mentoring skills; able to manage diverse relationships and work with higher management.
Core Competencies
• Intellectual Horsepower, Technical Ability, Team Building, Identifying and Developing Talent.
• Dealing with Ambiguity/Change, Manage Diverse Relationships, Organizational Ability.
• Comfort Around Higher Management.
Full Product Life Cycle & Cross-Functional Collaboration
• Demonstrated experience in full product life cycle development.
• Collaboration with cross-functional teams (software, mechanical, hardware, reliability, quality, and regulatory).
Communication Skills
• Superior written and verbal communication skills required.
Nice to Have
• Experience with designing for the Hardware/Firmware and wireless interfaces of electronic devices with user-centric design practices
• Knowledge of OOA&D and familiarity with UML is strongly desired.
• Experience working with designing systems in a regulated environment (e.g to meet ISO and Quality system regulation requirements, including IEC 60601-1, -2, -6, IEC 62304, ISO-14971, FDA 21CFR820.30, for Class I, II and III medical systems.
• Proven experience delivering software using .Net, C, Java, Python, Golang, or similar languages
• Understanding of cloud native architecture. AWS & Azure experience