Company Description SARACA is a global engineering R&D services company serving 25+ Fortune 500 customers across MedTech, Aerospace, Rail, Automotive, Semiconductor, Defense, and Farm industries. The company is ISO 13485 certified and has extensive experience with all classes of medical devices, including embedded software, UI/UX, mechanical, systems, and product testing. SARACA offers unique expertise in IEC 62304, EU MDR, clinical and performance evaluation reports, and scientific writing for MedTech. A leadership team with deep product engineering experience and a technically competent workforce of 400+ engineers and consultants deliver solutions to complex business problems worldwide. SARACA is an equal-opportunity employer that promotes a culture of innovation, continuous learning, and customer-focused growth.
Position Details
Role: Sr. Software Engineer – R&D
Location: Westford, MA – Onsite
Start Date: Immediate
Background Check: Mandatory
Position Overview
The Senior Software Engineer will be responsible for designing and developing robotics control, scheduling, and automation software for laboratory medical devices. The role involves developing low-level hardware communication and application-level device-control software, along with software testing, verification, validation, documentation, and investigation of on-market issues.
Key Responsibilities
- Design and develop software for medical devices while following established software development processes and healthcare industry regulations.
- Perform software development activities including design, coding, testing, verification, and validation.
- Develop low-level software enabling communication between hardware components and medical devices using C/C++/C#.
- Develop application-level software using state-machine/state-based design to control device behavior and performance.
- Support software verification and testing to ensure compliance with requirements, quality standards, and design specifications.
- Collaborate with multidisciplinary engineering teams to define requirements and develop reliable software solutions.
- Participate in design reviews, code reviews, software requirements development, and test documentation.
- Evaluate software designs through structured testing and document results.
- Investigate on-market software issues, perform root-cause analysis, identify corrective actions, and implement solutions within established software engineering processes.
- Provide technical guidance and support to junior engineers when required.
Required Technical Skills
- Strong hands-on experience with C, C++, and/or C#.
- Experience with Component Object Model (COM).
- State Machine Design and software design patterns.
- Device-level communications and hardware/software interfaces.
- Inter-Process Communication (IPC).
- Unit testing and mocking frameworks/environments.
- Test-Driven Development (TDD).
- CI/CD and automated software development pipelines.
- Experience working with Agile methodologies.
- Familiarity with Jira and Confluence.
- Strong understanding of component-level software design and development.
- Strong analytical, troubleshooting, and problem-solving skills.
- Ability to work independently and provide technical guidance to other engineers.
- Excellent verbal and written communication skills.
Preferred Qualifications
- 8+ years of software engineering experience with a Bachelor's degree, or 6+ years with a Master's degree.
- Experience developing software for medical devices or regulated healthcare environments.
- Knowledge of FDA regulations and Design Controls.
- Experience working with software requirements, hazard specifications, and traceability matrices.
Understanding of IEC 62304 – Medical Device Software Lifecycle Processes.
- Experience with Software Verification & Validation (V&V).
- Experience with automated testing and Hardware-in-the-Loop (HIL) testing.
- Experience performing root-cause analysis for complex system/software anomalies.
Regulatory & Quality Environment
This role requires development within a highly regulated medical-device environment. Software must maintain strong traceability between requirements, hazards, design, implementation, and verification activities, while adhering to applicable FDA requirements and IEC 62304 software lifecycle practices.
If you are interested and available for an onsite opportunity in Westford, MA, please share your updated resume and contact details for further consideration.
Best Regards,