Principal Medical Device Development Engineer (Embedded) IRC304687

Hitachi Careers•Waltham, MA

3d•Hybrid

About The Position

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. 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.

Requirements

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.
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, I²C, 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.
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.
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.

Nice To Haves

Experience with point-of-care or in-vitro diagnostic devices.

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.