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US_East | Product / System & PLM Engineer_L2
Datum Software, Inc
- 🇮🇱 Israel
- On-site
- Senior
- 1 month ago
- C++
- C#
- Jira
- Confluence
- Agile
- Test-Driven Development
- TDD
- CI/CD
- Unit Testing
- IEC
1 month ago
Work Location: Westford, MA (Onsite)
Job Summary
This company is a global healthcare organization developing diagnostic solutions, medical devices, nutritional products, and medicines.
The Senior Software Engineer will be responsible for developing robotics control, scheduling, and automation software for laboratory medical devices. This includes low-level hardware communication as well as application-level control software. The role also involves software testing, validation, documentation, cross-functional collaboration, and investigation of on-market issues.
Responsibilities:
- Help design and develop software that controls medical devices while following established development processes and healthcare industry regulations.
- Participate in software development activities, including design, coding, testing, and validation, to ensure software 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 cross-functional 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 enables hardware components and devices to communicate and function properly using programming languages such as C, C++, and C#.
- Develop application-level software that controls medical devices using state-based design methods to manage device behavior and performance.
- Assist in evaluating selected designs through testing and complete documentation of results.
- Investigate on-market software issues, determine appropriate corrective actions, and implement corrections in accordance with established software engineering processes.
- C / C++ / C#
- COM (Component Object Model)
- Jira and Confluence
- Agile methodologies
- Test-Driven Development (TDD)
- Continuous Integration and Continuous Delivery/Development (CI/CD)
- Software design patterns
- Unit testing and mocking
- Inter-Process Communication (IPC)
- State machine design
- Device-level communications
- Advanced experience designing and developing complex software systems.
- Ability to provide technical guidance and support to junior team members.
- Advanced knowledge of modern programming languages, including C, C++, and C#.
- Strong experience working in Agile development environments.
- Advanced understanding of test-driven development methodologies.
- Advanced knowledge of continuous integration and continuous delivery/development practices.
- Demonstrated technical proficiency, creativity, independent thinking, and problem-solving ability.
- Excellent verbal and written communication skills.
- Ability to develop and design software at the component level.
- Advanced understanding of software design patterns.
- Strong analytical and problem-solving skills.
- 8 years of relevant experience with a Bachelor's degree, or 6 years of relevant experience with a Master's degree.
- Experience with unit testing and mocking frameworks/environments.
- Experience within the medical device and regulatory domain.
FDA & Design Controls:
Engineering work must comply with applicable FDA regulations. Software code must map directly to comprehensive software requirements, hazard specifications, and detailed traceability matrices.
Standards Compliance:
Software architecture must closely adhere toIEC 62304 – Medical Device Software Lifecycle Processes.
Verification & Validation (V&V):
Testing extends beyond standard unit testing and includes structured automation, Hardware-in-the-Loop (HIL) testing pipelines, system-level verification, validation, and root-cause analysis of system anomalies.
“All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.”
US_East | Product / System & PLM Engineer_L2 · Datum Software, Inc