Software Innovator

2 days ago

Islamabad, Islamabad, Pakistan beBeeSoftware Full time
Senior Software Architect for Medical Devices

This is a unique and challenging position that requires a lead programmer to drive product and company success.

The core product is programmed in SWIFT and runs on an iPad Pro 11-inch tablet using the Apple Pencil 2 Stylus.

We utilize a combination of EC2 instances with Django, Gunicorn, and Nginx; AWS cloud, Amazon RDS (PostgreSQL), S3 and Amazon CloudFront, and Heroku. Please note that some components might have changed in the newest release and the new team is able to restructure them.

An admin panel website and various API/SDK's from 3rd party apps and unrestricted open-source code are also used.

Job Requirements

Key Responsibilities:

  1. Lead transition process from old software team to you and your team. Assist in creation of a small team of 2-3 core programmers.
  2. 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.
  3. Develop and improve software architecture by weighing pros and cons with options.
  4. Lead programming team and communicate with management when additional people are required full time or for specific contracted roles.
  5. Comprehend regulations and ensure all clauses are systematically designed, implemented, and verified.
  6. Implement an effective risk management process that identifies and mitigates potential hazards throughout the software's lifecycle, in alignment with ISO 14971 standards.
  7. Evaluate Quality Management System (QMS) per FDA's Quality System Regulation (QSR) and ISO 13485.
  8. Direct and perform Validation and Verification (V&V) activities ensuring that the software/device meet user needs, intended uses, and consistently fulfills all requirements.
  9. Implement design controls in compliance with FDA regulations.
  10. Cybersecurity Governance: Address potential vulnerabilities, strategize, and oversee cybersecurity in compliance with FDA guidelines.
  11. Data Integrity and Security: Ensure robust data integrity, security, and compliance with laws like HIPAA and GDPR.

Qualifications:

  1. Full stack programming background required.
  2. Clear experience and success in senior programming roles required.
  3. Prior experience in medical software and/or devices is recommended, but not required.
  4. Familiarity with regulatory standards is beneficial, but the ability to learn and apply these regulations is also acceptable.
  5. High intelligence required.

Job Type: Full-time

Application Question(s):

  1. Please describe your greatest accomplishment.
  2. Please provide any metrics that would be useful in understanding your credentials.

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