1 day ago
Bengaluru, IndiaMid Level
Responsibilities
- Plan, coordinate, and document software documentation and post-production deliverable updates according to established procedures and schedules.
- Maintain electronic software DHF and TFS repositories and monitor required approval cycles.
- Collaborate with onshore and offshore Software Verification and Validation teams to provide test-cycle inputs and update documentation after testing.
- Support audits, regulatory activities, compliance requests, and updates driven by regulatory changes.
- Support the Lake Forest software development team and ensure compliance with software release procedures for post-market changes.
Requirements
- Bachelor’s degree in Computer Science, Software Development, MIS, BIS, or a related discipline with two years of experience, or five years of relevant experience.
- Knowledge of ISO 14971 and ISO 13485 or US 21 CFR 820.30, systems engineering or medical-device risk management, and software development lifecycle management.
- Preferred knowledge of IEC 62304 and experience with PLM Windchill, Microsoft Visual Studio, Azure DevOps, or other IDE tools.
- Intermediate Microsoft Word skills, including tables of contents, tables, and macros.
- Strong technical and scientific writing, verbal English communication, independent problem-solving, organization, and cross-functional collaboration skills.
- Preferred certifications or knowledge in medical-device risk management, design controls, and medical-device software lifecycle processes.
Benefits
- Work hours are 1 PM to 10 PM IST.
- Relocation assistance is provided.
- The role operates in a virtual, remote, and asynchronous environment.
Tech Stack
TensorFlow