Job Description
Role Description
- Drive end-to-end Software Development Life Cycle (SDLC) for healthcare projects (SAMD).
- Translate complex system-level requirements into actionable software use cases and user stories.
- Support team with design inputs that strictly adhere to the Arthrex Quality Management System (QMS) and international regulatory frameworks to minimize compliance risks.
- Take ownership of the Design History Files (DHF) and Design Control Documentation including maintaining technical records and coordinating with regulatory teams to ensure a seamless path to certification and market entry.
- Provide technical support during high-stakes audits conducted by the FDA, Notified Bodies, and other regulatory agencies by maintaining transparent and accurate documentation.
- Actively monitor software project health, identify potential bottlenecks early, and implement corrective actions to keep the development schedule on t...
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