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Aita Consulting Services, Inc
Sr. Software Engineer R&D (Medical Devices)Aita Consulting Services, Inc • Westford, MA, United States
Sr. Software Engineer R&D (Medical Devices)

Sr. Software Engineer R&D (Medical Devices)

Aita Consulting Services, Inc • Westford, MA, United States
5 hours ago
Job type
  • Full-time
  • Quick Apply
Job description

Role Name: Sr. Software Engineer R&D (Medical Devices)

Work Location: Westford MA (Onsite)

This company is a global healthcare company developing diagnostic solutions, medical devices, nutritionals, and medicines. The Senior Software Engineer will develop robotics control, scheduling, and automation software for laboratory medical devices, including low-level hardware communication and application-level control. The role also involves software testing, validation, documentation, cross-functional collaboration, and investigating on-market issues.

Responsibilities:

  • Help design and develop software that controls medical devices, following established development processes and healthcare industry regulations
  • Participate in software development activities, including designing, coding, testing, and validating software to ensure it performs safely and reliably
  • Support testing efforts to verify that software meets requirements, follows quality standards, and complies with design specifications
  • Collaborate with engineers and other team members across multiple disciplines to develop software solutions, define requirements, and document design and testing activities
  • Contribute to technical documentation, including design reviews, code reviews, software requirements, and testing results
  • Develop and maintain low-level software that allows hardware components and devices to communicate and function properly using programming languages such as C++, C#
  • Develop application-level software that controls medical devices using state-based design methods to manage device behavior and performance
  • Assist in the evaluation of selected designs through testing and full documentation of the results
  • Investigate on-market issues, determine appropriate corrections, and implement those corrections underneath our software engineering process.

Qualification:

  • C/C++/C#
  • COM (Component Object Model)
  • Jira and Confluence
  • Agile Methodologies
  • Test-Driven Development
  • Continuous Integration and Continuous Delivery (CI/CD)
  • Software Design Patterns
  • Unit Testing and Mocking
  • Inter-Process Communication
  • State Machine Design
  • Device-Level Communications
  • Advanced experience in designing and developing complex software systems
  • Ability to provide guidance to junior team members
  • Advanced knowledge in modern programming languages such as C/C++/C# & agile methodologies
  • Advanced level of understanding of test-driven methodologies
  • Advanced level of knowledge with continuous integration & continuous development (CI/CD)
  • Demonstrated success in technical proficiency, creativity, and independent thought
  • Excellent verbal and written communication skills
  • Ability to develop & design at the component-level
  • Advanced level understanding of design patterns
  • Strong analytical & problem-solving skills

Preferred:

  • 8 years of experience and a BS degree or 6 years with MS degree
  • Experience with unit testing and mocking environments
  • Medical Device & Regulatory Domain
  • FDA & Design Controls: Engineering at company mandates strict compliance with FDA regulations. Code must map directly to comprehensive software requirements, hazard specifications, and detailed traceability matrixes.
  • Standard Compliance: Code architectures must closely adhere to IEC 62304 (Medical device software lifecycle processes)
  • Verification & Validation (V&V): Testing goes far beyond standard unit testing. It incorporates rigid automation, Hardware-in-the-Loop (HIL) testing pipelines, and root-cause analysis for system anomalies

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Sr. Software Engineer R&D (Medical Devices) • Westford, MA, United States

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