Principal Embedded Engineer (Medical Device)

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.