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Experience: 5 to 9 years
Location - Pune
Responsibilities:
- Hands-on experience in Product development lifecycle – preferred Medical devices
- Solid understanding of software requirements and associated protocols.
- In-depth knowledge of ISO 13485, ISO 14971, 21 CFR Part 11, EU MDR, IEC 60601, and familiarity with IEC 62304 for software lifecycle documentation.
- Able to Manage all Verification and Validation activities and deliverables for New Product Development and Strong technical expertise in electro-mechanical systems, including requirements and protocol interpretation.
- Proven experience in data migration across PLM systems (e.g., Siemens Teamcenter, PTC Windchill), eQMS platforms (e.g., ETQ, TrackWise), ERP/MES, Jama, RQM, DNG, and ALM/requirements management tools.
- Demonstrated ability to maintain traceability (requirements to design inputs to verification/validation) and ensure DHF/DMR integrity throughout the process.
- Preferred experience in PLM tool validation, including IQ/OQ/PQ (Installation, Operational, and Performance Qualification), compliance documentation, and validation of PLM-related software tools in regulated environments
- Perform systemic review of Test Cases to ensure that both typical use and edge cases are properly covered (happy-path, alternate path, negative path, etc.)
- Strong design control and documentation skills
- Good technical writing skills, including understanding of requirements, test methods, protocols
- Able to work independently and in a team environment
- Excellent problem-solving skills
