Sr. Software Engineer R&D (medical devices)

Role name: Sr. Software Engineer R&D

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