
Senior Software Architect For Medical Device Software
2 days ago
We are seeking an experienced Senior Full Stack Developer to lead our programming department and drive the development of our medical device software. As a key member of our team, you will be responsible for leading the transition from our current software prototype, managing the Software Development Life Cycle (SDLC), and ensuring compliance with FDA guidelines and IEC 62304.
Key Responsibilities:
- Transition and Transform Current Software Prototype: Lead the transition process from our old software team to your team, assisting in the creation of a small team of core programmers.
- Manage SDLC: Drive all stages of the SDLC, ensuring our medical device software aligns with FDA guidelines & IEC 62304 from prototype to deployment and maintenance.
- Architecture & Programming: Develop and improve software architecture by weighing pros and cons with options.
- Team Management: Lead our programming team and communicate with the CEO when additional people are required full time or for specific contracted roles.
- Regulatory Learning: Learn regulations alongside the CEO and regulatory expert on the team, comprehending regulations and ensuring all clauses are systematically designed, implemented, and verified.
- Risk Management: Implement an effective risk management process that identifies and mitigates potential hazards throughout the software's lifecycle.
- Quality Management: Establish a robust Quality Management System (QMS) per FDA's Quality System Regulation (QSR) and ISO 13485.
- Validation and Verification (V&V) Leadership: Direct and perform V&V activities ensuring that the software/device meet user needs, intended uses, and consistently fulfills all requirements.
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