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Advanced Software Engr
ConfidentialBengaluru / Bangalore30+ days ago
Job descriptionAct as SME for global medical device manufacturing compliance (DHF, DHR, MDR). Prioritize and manage product backlog aligned with regulatory demands and business value. Engage with cross-functional teams to ensure agile delivery of validated digital solutions. Drive continuous improvement and regulatory readiness through digital transformation initiatives.
Key Deliverables :
- Define the vision, roadmap, and compliance-focused features for Electronic Device History Record (EDHR) platforms.
- Translate regulatory frameworks (21 CFR Part 820, EU MDR, ISO 13485) into digital product specifications.
- Lead integration of EDHR with MES, PLM, and QMS systems in medical device manufacturing environments.
- Support technical pre-sales, audits, and validations to ensure adherence to regulatory standards.
Role Responsibilities :
Skills Required
Iso 13485, Plm, Mes
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Advanced Software Engr • Bengaluru / Bangalore