Advanced Software Engr

Key Deliverables:

1. Define the vision, roadmap, and compliance-focused features for Electronic Device History Record (EDHR) platforms.
2. Translate regulatory frameworks (21 CFR Part 820, EU MDR, ISO 13485) into digital product specifications.
3. Lead integration of EDHR with MES, PLM, and QMS systems in medical device manufacturing environments.
4. Support technical pre-sales, audits, and validations to ensure adherence to regulatory standards.

Role Responsibilities:

1. Act as SME for global medical device manufacturing compliance (DHF, DHR, MDR).
2. Prioritize and manage product backlog aligned with regulatory demands and business value.
3. Engage with cross-functional teams to ensure agile delivery of validated digital solutions.
4. Drive continuous improvement and regulatory readiness through digital transformation initiatives.