Hi Associate,
Greetings for the day,
We have a position as a Principal Embedded Engineer (Medical Device) role in Waltham, MA. Please find the job description below for this position.
Role: Principal Embedded Engineer (Medical Device)
Location: Waltham, MA (Hybrid)
Duration: 24 Months+
Job Description
Required Qualifications:
- Bachelor s or Master s degree in Computer Science, Software Engineering, Computer Engineering, Electrical Engineering, Biomedical Engineering, or a related technical discipline.
- Typically, 10 15+ years of professional embedded software or firmware development experience.
- Demonstrated experience operating at Principal Engineer, Senior Staff Engineer, Software Architect, or equivalent technical-leadership level.
- Strong hands-on experience developing embedded software in C and/or C++.
- Experience developing software for regulated medical devices, IVD systems, healthcare products, or another safety-critical regulated industry.
- Experience with the complete embedded software lifecycle, including requirements, architecture, design, implementation, integration, verification, release, and maintenance.
- Strong understanding of embedded-system architecture and hardware-software interaction.
- Experience debugging complex embedded systems using appropriate hardware and software tools.
- Experience developing and maintaining multithreaded, real-time, or event-driven embedded applications.
- Experience with embedded operating systems, embedded Linux, or real-time operating systems.
- Experience with device drivers, hardware abstraction, communication interfaces, and peripheral integration.
- Strong understanding of software architecture, modular design, state machines, memory management, concurrency, and fault handling.
- Experience with source control, configuration management, code reviews, defect tracking, and controlled software releases.
- Ability to analyze and improve large or legacy embedded codebases.
- Experience producing high-quality technical and software lifecycle documentation.
- Strong analytical, troubleshooting, and root-cause-analysis skills.
- Ability to lead technical work through influence without direct management authority.
- Excellent written and verbal English communication skills.
Embedded Technical Skills:
- Advanced C and/or C++ development.
- Embedded Linux and/or RTOS development.
- Multithreaded and real-time software design.
- Low-level firmware and device-driver development.
- Hardware abstraction layer design.
- Board bring-up and hardware-software integration.
- Inter-process communication and event-driven architectures.
- Serial and hardware communication protocols such as UART, SPI, I C, USB, CAN, or Ethernet.
- Network communication and device-connectivity protocols.
- Memory, performance, timing, and resource optimization.
- Error handling, fault detection, diagnostics, logging, and recovery mechanisms.
- Unit testing, integration testing, static analysis, and code-coverage analysis.
- Debugging tools such as JTAG, oscilloscopes, logic analyzers, protocol analyzers, and embedded debuggers.
- Build systems, cross-compilation toolchains, and CI/CD pipelines.
- Secure coding and embedded cybersecurity principles.
Medical-Device Responsibilities:
- Develop software in compliance with applicable quality-system procedures.
- Ensure that embedded software development follows IEC 62304 lifecycle processes.
- Support software safety classification and risk-based development activities.
- Contribute to hazard analysis and software-related risk assessment.
- Implement and document software risk-control measures.
- Maintain traceability between requirements, risks, architecture, implementation, and verification.
- Produce or review software development plans, requirements, architecture, detailed designs, test documentation, anomaly assessments, and release records.
- Support Design History File creation and remediation.
- Participate in formal design reviews.
- Ensure unresolved software anomalies are properly evaluated and documented.
- Support software validation, regulatory submissions, audits, and inspections.
- Contribute to cybersecurity threat analysis, vulnerability assessment, and remediation.
Regulatory and Standards Experience
Practical experience with several of the following:
IEC 62304.
ISO 13485.
ISO 14971.
FDA Design Controls.
FDA 21 CFR Part 820.
FDA guidance for medical-device software.
IEC 62366-1.
FDA cybersecurity guidance.
EU MDR or IVDR.
Secure software-development lifecycle practices.
Medical-device verification and validation.
Preferred Qualifications:
Experience with point-of-care or in-vitro diagnostic devices.
Job Responsibilities:
- Provide technical leadership for embedded software development and sustaining-engineering activities.
- Design, implement, debug, test, and maintain embedded software and firmware for medical devices.
- Define and evolve embedded software architecture, component boundaries, interfaces, and data flows.
- Analyze legacy software to understand existing behavior, architecture, dependencies, and technical limitations.
- Resolve complex software, firmware, hardware-integration, performance, reliability, and field issues.
- Translate system and product requirements into clear, testable software requirements and technical designs.
- Decompose system-level requirements into embedded software components and interfaces.
- Ensure alignment between software requirements, architecture, detailed design, implementation, risk controls, and verification evidence.
- Participate in and lead technical reviews, software design reviews, code reviews, and root-cause investigations.
- Collaborate with electrical and systems engineers on hardware-software interfaces, sensors, communication protocols, diagnostics, and device behavior.
- Develop low-level drivers, device-control logic, hardware abstraction layers, communication components, and application-level embedded functionality.
- Support integration between embedded devices and external systems such as middleware, host applications, hospital networks, or cloud services.
- Perform technical impact analysis for software changes, defects, anomalies, component updates, and cybersecurity vulnerabilities.
- Support software remediation by identifying gaps between documented requirements and implemented behavior.
- Create or update software lifecycle documentation required for the Design History File.
- Ensure complete bidirectional traceability between requirements, risks, design, code, tests, defects, and release evidence.
- Collaborate with V&V and Software Quality teams to define verification approaches and improve testability.
- Support unit, integration, system, regression, performance, reliability, and cybersecurity testing.
- Investigate field-reported issues and support corrective and preventive actions.
- Support controlled software builds, releases, configuration management, and design changes.
- Contribute to product risk analysis and ensure that software-related risk controls are properly implemented and verified.
- Support internal audits, regulatory inspections, and submission-related activities.
- Mentor software engineers and promote effective embedded-development and documentation practices.
- Identify architectural improvements and technical-debt reduction opportunities.
- Drive continuous improvement of software engineering processes, tools, code quality, and development efficiency.
Department/Project Description
Project Overview
The customer is a global medical-device company developing point-of-care diagnostic systems used in hospitals and clinical environments.
The project supports the development, maintenance, and remediation of an established medical-device product line. The scope includes embedded software development, analysis of existing implementations, resolution of design and documentation gaps, product improvements, and support throughout the regulated medical-device lifecycle.
We are looking for a Principal-level Embedded Software Engineer who can provide hands-on technical leadership and solve complex system and software problems in a regulated environment.
Role Overview
- The Principal Medical Device Embedded Software Engineer will serve as a senior individual contributor responsible for the architecture, design, implementation, integration, and maintenance of embedded software for regulated medical devices.
- The role requires deep embedded-development expertise combined with practical knowledge of medical-device design controls, risk management, verification, traceability, and Design History File documentation.
- The engineer will work closely with Systems Engineering, Electrical Engineering, Software Quality Assurance, Verification and Validation, Regulatory Affairs, Manufacturing, and other cross-functional stakeholders.
- This is not a people-management position. The successful candidate will lead through technical ownership, architectural decision-making, mentoring, and cross-functional influence.
