Principal Medical Device Development Engineer (Embedded) IRC307364

GlobalLogic Inc.; États-Unis; Hybride; USD 145 000 - 155 000; Plein temps

Résumé du poste

GlobalLogic Inc. in Waltham, MA is seeking a Principal Medical Device Embedded Software Engineer to lead architecture, design, and implementation of embedded software for regulated medical devices in a hybrid role.

You will collaborate with Systems, Electrical, QA, Regulatory Affairs, and Manufacturing teams to drive safe, compliant software across the lifecycle. The role emphasizes technical ownership, risk management, Design History File contribution, and cross-functional influence in a

Qualifications

• Extensive embedded software development experience in regulated environments.
• Experience with IEC 62304, ISO 13485, ISO 14971, FDA Design Controls.
• Experience in design controls and software lifecycle for medical devices.
• Strong analytical and problem-solving skills.

Responsabilités

• Lead architecture, design, implementation, integration, and maintenance of embedded software for regulated medical devices.
• Collaborate with Systems, Electrical, QA, Regulatory Affairs, Manufacturing, and other cross-functional teams.
• Support regulatory submissions and audits and contribute to Design History File documentation.
• Produce and review software development plans, requirements, architecture, detailed designs, test documentation, and release records.

Connaissances

C/C++

Embedded Linux/RTOS

Multithreaded real-time design

Device drivers & HAL

Hardware-software integration

Debugging complex systems

Requirements & verification

English communication

Formation

Bachelor’s or Master’s degree in Computer Science/Engineering

Outils

JTAG

Oscilloscopes

Logic analyzers

Protocol analyzers

CI/CD pipelines

Cross-compilation toolchains

Description du poste

Principal Medical Device Development Engineer (Embedded) IRC307364

Function

IT, Telecom & Internet

Experience

10-15 years

Location

United States - Waltham MA

Skills

C, Debugging, FDA 510(k), Healthcare-Medical Devices, I2C, RTOS, SPI, Verification

Description Note: GlobalLogic estimates the starting pay range for this role to be performed hybrid in Waltham, MA is $145,000 – $155,000 and reflects base salary only. This pay range is provided as a good faith estimate and the amount offered may be higher or lower. GlobalLogic takes many factors into consideration in making an offer, including candidate qualifications, work experience, operational needs, travel and onsite requirements, internal peer equity, prevailing wage, responsibilities, and other market and business considerations.

Role: Lead Embedded Engineer Location:Waltham, MA (Hybrid)

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.

Requirements

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, 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.
• 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