Senior Full Stack Developer / Architect For Software As A Medical Device

Senior Full Stack Developer / Architect For Software As A Medical Device

Opening Statement :

This is a unique and challenging position. We are seeking a lead programmer obsessed with product and company success. We are offering competitive starting pay with the opportunity for major incentives / raises / bonuses. Expectations are high and the selected candidate will be responsible for leading the programming department and learning / applying new skills specific to this position. This position will inherently require that the applicant be adaptable. A thorough understanding of systems and Software Development Lifecycle (SDLC) is required. The core product is programmed in SWIFT and runs on an iPad Pro 11-inch tablet using the Apple Pencil 2 Stylus. Our backend uses a combination of the following : EC2 instances with Django, Gunicorn, and Nginx; AWS cloud, Amazon RDS (PostgreSQL), S3 and Amazon CloudFront, and Heroku. Please note that some of these components might have changed in the newest release and the new team is able to restructure them. We also utilize an admin panel website and various API / SDK’s from 3rd party apps and unrestricted open-source code. Job Specification

Key Responsibilities : Transition and Transform Current Software Prototype : Lead transition process from old software team to you and your team. Assist in creation of a small team of 2-3 core programmers. Manage SDLC : Drive all stages of the Software Development Life Cycle (SDLC), ensuring our medical device software aligns with FDA guidelines & IEC 62304 from prototype to deployment and maintenance. Architecture & Programming : Pragmatically develop and improve software architecture by weighing pros and cons with options (e.g., determine when we should program aspects ourselves vs. using open source, API, out of the box solutions, etc.). Team Management : Lead our programming team and communicate with CEO when additional people are required full time or for specific contracted roles (e.g., we might hire a cybersecurity expert for 1 month of work). Regulatory Learning : It is likely that the applicant will not have experience in all required regulatory areas. As such, it will be mandatory for candidate to learn these regulations alongside the CEO and regulatory expert on the team. The selected candidate will need to comprehend regulations and ensure 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, in alignment with ISO 14971 standards. 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. Design Control Procedures : Implement design controls in compliance with FDA regulations (21 CFR 820.30). Cybersecurity Governance : Address potential vulnerabilities, strategize, and oversee cybersecurity in compliance with FDA guidelines. Data Integrity and Security : Ensure robust data integrity, security, and compliance with laws like HIPAA and GDPR. Qualifications : Full stack programming background required. Clear experience and success in senior programming roles required. Prior experience in medical software and / or devices is recommended, but not required. Familiarity with regulatory standards (CFR 820, CFR 21 part 11, IEC 62304, ISO 13485, and relevant security guidelines) is beneficial, but the ability to learn and apply these regulations is also acceptable as guidance will be provided. High intelligence required. A steep learning curve will be necessary to learn various regulations. Job Type : Full-time Application Question(s) : Please describe your greatest accomplishment. Please provide any metrics that would be useful in understanding your credentials. For example, metrics that describe your academic experience, intelligence, test scores, team sizes you've worked with, etc. Location : Biotechnology - Nowshera Cantonment, Pakistan

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