Posted:1 month ago|
Platform:
Hybrid
Full Time
Job Summary:
We are seeking a skilled and motivated Senior Software Engineer to join our cross-functional product development team. This role is responsible for developing an automated solution that performs risk assessment and generates reports for SOUP (Software of Unknown Provenance) and third-party software libraries that are used in the Medical Devices, ensuring that our medical devices are designed, developed, and maintained with the highest standards and in compliance with the Medical Device Standards. You will work closely with engineering, quality, IT, and regulatory teams.
Key Responsibilities:
Collaborate with cross functional teams to Identify and document SOUP (Software of Unknown provenance) components and requirements as applicable for the Medical Device.
Robust solution design using tools like Enterprise Architect, UML, UI/UX etc.
Software design and development of enterprise applications, including the development of database and Software Unit Test & Integration plans and protocols.
Develop test automation framework and test scripts.
Participates in reviews, code inspections and will support the development of documentation required for FDA device approval.
Work effectively within geographically dispersed and cross-functional teams during all phases of the product development process.
Must be responsive, flexible, self-motivated and able to succeed within an open collaborative peer environment
Highly effective, agile and thrives in a dynamic environment with multiple, changing priorities
Comfortable with proactive outward communication and never shies away from a challenge
Be Agile and effectively navigate through changing project priorities.
Qualifications:
Required:
A bachelors degree in computer science, Electrical, Electronics / equivalent from reputed institution.
8 to 10 years experience in Enterprise Software development in regulated industry.
Strong experience in Python, TypeScript, SQL, SnowFlakes, Docker
Good to have programming skills using C++ and Object-Oriented principles.
Experience working in a structured software development environment following a well-defined software development process like Agile / Lean.
Experience with software risk analysis (per ISO 14971) including software failure mode and effects analysis (FMEA).
Key Skills:
Strong analytical and problem-solving skills
Excellent communication and documentation abilities
Team player with cross-functional collaboration experience
Strong attention to detail and regulatory mindset
Horizontal Integration
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