Jobs · Massachusetts

Principal Medical Device Development Engineer (Embedded) IRC304687

GlobalLogic · Waltham, MA · 1 mo ago
$145k–$155k/yrFull-time
We need to output HTML fragment with headings

for sections present: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must include only sections with real content. The posting includes: - Project Overview (maybe part of About the role) - Role Overview (maybe About the role) - Requirements (list of required qualifications) - Embedded Technical Skills (maybe Skills) - Medical-Device Responsibilities (maybe Responsibilities) - Regulatory And Standards Experience (maybe Qualifications? but could be part of Requirements) - Preferred Qualifications (maybe Qualifications) - Job responsibilities (Key Responsibilities) (Responsibilities) - What we offer (Benefits) - Pay: there is a note about pay range: "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." So we have Pay info. - Schedule: Not explicitly mentioned; maybe hybrid location but no schedule details. So we should not create Schedule section if no content. We must not repeat job title as heading. Also not include Job ID etc. We need to preserve all substantive info, not invent or summarize away detail. Use
  • for any list of duties/requirements/benefits, and

    for prose. We need to decide sections: - About the role: could combine Project Overview and Role Overview (maybe also location/hybrid). Provide prose. - Responsibilities: list of key responsibilities (the "Key Responsibilities" bullet list). Also maybe Medical-Device Responsibilities? But those are more about compliance; could be part of Responsibilities or Qualifications. We'll treat Medical-Device Responsibilities as part of Responsibilities (since they are duties). Could also be separate but we want few substantive sections. - Requirements: list of required qualifications (the "Required Qualifications:" block). Also maybe Regulatory And Standards Experience as part of Requirements? It's more like required experience; could be included under Requirements. - Skills: Embedded Technical Skills list. - Qualifications: Preferred Qualifications maybe. - Benefits: What we offer list. - Pay: the pay range note. We must not create sections with filler like "commensurate with experience". We have actual pay range. We need to output only HTML fragment, no /. Use

    for each section heading. We must not include markdown fences. Let's craft. First, About the role: combine Project Overview and Role Overview. Provide paragraphs. 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." 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." We can put these as

    elements. Next Responsibilities: list of key responsibilities (the "Key Responsibilities" bullet list). Also include Medical-Device Responsibilities maybe as part of same list? But we can separate: maybe two lists: Responsibilities (key responsibilities) and Medical-Device Responsibilities (compliance). However to keep few sections, we could combine them under Responsibilities with two

      lists? But spec says use
      • for any list of duties/requirements/benefits. It doesn't forbid multiple lists within a section. So we can have one Responsibilities section with multiple
          lists: one for key responsibilities, another for medical-device responsibilities. We'll output:

          Responsibilities

          • Provide technical leadership for embedded software development and sustaining-engineering activities.
          • ... etc (list all key responsibilities)
          • Develop software in compliance with applicable quality-system procedures.
          • ... etc (list medical-device responsibilities)
          We need to ensure we include all items from both lists. Let's extract key responsibilities list from posting: "Key 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." That's a long list; we need to capture each as
        • . We'll need to split by sentences that start with a verb. We'll just copy each line as separate
        • . Ensure we keep the exact phrasing. Now Medical-Device Responsibilities list: "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." We'll make
            for that. Next Requirements: list of required qualifications. From posting: "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." We'll make
              . Next Skills: Embedded Technical Skills list. "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." Make
                . Next Qualifications: Preferred Qualifications. "Preferred Qualifications Experience with point-of-care or in-vitro diagnostic devices." That's a single item; we can still make
                  with one
                • . Next Benefits: What we offer. "What we offer Exciting Projects:Come take your place at the forefront of digital transformation! With clients across all industries and sectors, we offer an opportunity to work on market-defining products using the latest technologies. Collaborative Environment: You can expand your skills by collaborating with a diverse team of highly talented people in an open, laidback environment — or even abroad in one of our global centers or client facilities! Work-Life Balance:GlobalLogic prioritizes work-life balance, which is why we offer flexible work schedules and opportunities to work from home. Professional Development:We provide continuing education classes, professional certification and training (technical, soft skills, language, and communication skills) to help you realize your professional goals. Being part of a global organization, there are additional learning opportunities through international knowledge exchanges. Excellent Benefits:We provide our employees with competitive salaries, health and life insurance, short-term and long-term disability insurance, a matched contribution 401K plan, flexible spending accounts, and PTO and holidays" We need to turn into prose or list? The instruction: Use
                  • for any list of duties/requirements/benefits, and

                    for prose. Benefits is a list of items; we can make

                      with each benefit as
                    • . However the text is colon-separated phrases. We'll split by sentences after each benefit? Let's extract: - Exciting Projects: Come take your place at the forefront of digital transformation! With clients across all industries and sectors, we offer an opportunity to work on market-defining products using the latest technologies. - Collaborative Environment: You can expand your skills by collaborating with a diverse team of highly talented people in an open, laidback environment — or even abroad in one of our global centers or

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