Job Description:
Key Responsibilities:
- Own, manage and prioritize requirements in the product life cycle from definition to phase-out.
- Define requirements for native, on-premises, and cloud deployments.
- Provide clear direction, context, and priorities to development teams.
- Collaborate closely with key internal stakeholders and engage with external stakeholders.
Focus Areas:
- Must - Basic understanding of DICOM, IHE, Legal regulations and standards applicable for medical devices, affecting safety aspects (i.e. FDA 21CFR820QSR, ISO 13485)
- Must - Knowhow of Containers, Kubernetes, Dockers and other Containerization technologies.
- Must - Knowledge on serviceability, Infrastructure, and product deployment technologies.
- Must - Good programming skills & should have worked for a majority of time in software programming roles.
- Must - Agile Methodologies, Product Lifecycle Management & Software development cycle experience for Medical Devices
- Must- Experience in Requirements Engineering, Usability Engineering and feature definition activities.
Nice to have - knowledge of Clinical workflows
What are my tasks
- Gather, prioritize, create & communicate stakeholder and market requirements & S/W specifications
- Guide and support development teams, resolving conflicts and answering questions
- Manage all the Agile methodology practices related to requirements engineering and product definition
- Provide input to project management and support rollout activities such as training, presentations, and workshops
What do I need to know to qualify for this job
Qualification: A Bachelors / Masters degree in engineering and / or MCA or equivalent.
Work Experience: 12 to 15 years
Desired Knowledge & Experience:
- Self-driven & problem-solving behavior, clear written and spoken communication skills.
- Willingness to constantly learn & un-learn to improve self.
- A strong background in software development, ideally with hands-on programming experience and agile methodologies is required.
- The role demands experience in requirements engineering, product lifecycle management, and IT integration in regulated environments.