Sr Software Systems Engineer R&D

Position Summary:

The Senior Software R&D Systems Engineer provides technical leadership for software-intensive sustaining initiatives across a portfolio of blood and cell therapy capital equipment systems. This role leads the definition, integration, and validation of complex systems with a strong emphasis on software architecture, software-hardware interaction, and system-level behavior in a highly regulated environment following the INCOSE principles and values.

Focused on sustaining and lifecycle management activities, this position ensures that software changes—driven by compliance, serviceability, cybersecurity, reliability, and cost—are safely and effectively integrated into existing platforms. The Senior Software R&D Systems Engineer partners closely with software, hardware, quality, manufacturing, and service teams to ensure continued system performance, reliability, and regulatory compliance.

Key Responsibilities:

Software-Centric Systems Engineering Leadership

• Lead systems engineering activities for software-intensive sustaining projects across compliance, service, cybersecurity, and cost initiatives.
• Own system- and software-level requirements, architecture, interfaces, and traceability for existing products.
• Apply disciplined software systems engineering practices aligned with regulated SDLC frameworks, V-Model execution, and MBSE principles.
• Serve as the technical integrator between software, electrical, mechanical, and system components.

Architecture, Integration & Risk Management

• Define and maintain software-centric system architectures, including software-hardware interfaces and data flows.
• Conduct trade studies, impact analyses, and architectural assessments for software changes in complex systems.
• Lead system-level risk management activities, including software hazard analysis, cybersecurity risk assessment, and root cause investigations.
• Ensure software changes preserve system safety, performance, reliability, and usability.

Verification, Validation & Regulated SDLC

• Define and execute software-focused system verification and validation strategies, including development of test plans, protocols, and reports.
• Ensure software requirements are fully traceable through implementation, verification, and validation.
• Support compliance with Medical Industry regulatory requirements, industry standards, and internal Quality Management System (QMS) processes.
• Maintain audit-ready documentation supporting software lifecycle and system changes.

Cross-Functional & Technical Collaboration

• Partner closely with Software Engineering, Systems, Quality, Manufacturing, Cybersecurity, and Service teams to drive integrated execution.
• Act as a technical authority for software-related system behavior, dependencies, and failure modes.
• Support software release activities, system integration testing, and field issue resolution.

People Leadership & Technical Mentorship

• Mentor and guide software and systems engineers on software-centric systems engineering best practices.
• Contribute to the definition and continuous improvement of software systems engineering processes and standards.
• Influence technical direction across distributed, matrixed R&D organizations.

Qualifications:

• Bachelor’s or Master’s degree in Software Engineering, Computer Engineering, Systems Engineering, or a related technical discipline. (Master’s degree preferred)

Required:

Experience

• 5+ years of experience in systems engineering roles with strong software focus.
• Proven experience working on software-intensive, multidisciplinary systems in regulated environments.
• Demonstrated experience with regulated software development lifecycles, V-Model execution, and systems engineering best practices.
• Experience supporting sustaining engineering, post-market changes, and software lifecycle management.
• Experience in medical devices or other highly regulated industries (e.g., cybersecurity, financial services platforms, aerospace) preferred.

Technical Skills

• Strong understanding of software architecture, system integration, and software-hardware interaction.
• Experience with requirements management, system modeling, and traceability tools.
• Familiarity with engineering and analysis tools (e.g., MATLAB, Minitab, modeling tools); software design and analysis tools a plus.
• Knowledge of cybersecurity, safety-critical software, or regulated embedded systems is highly desirable.

Position Summary:

The Senior Software R&D Systems Engineer provides technical leadership for software-intensive sustaining initiatives across a portfolio of blood and cell therapy capital equipment systems. This role leads the definition, integration, and validation of complex systems with a strong emphasis on software architecture, software-hardware interaction, and system-level behavior in a highly regulated environment following the INCOSE principles and values.

Focused on sustaining and lifecycle management activities, this position ensures that software changes—driven by compliance, serviceability, cybersecurity, reliability, and cost—are safely and effectively integrated into existing platforms. The Senior Software R&D Systems Engineer partners closely with software, hardware, quality, manufacturing, and service teams to ensure continued system performance, reliability, and regulatory compliance.

Key Responsibilities:

Software-Centric Systems Engineering Leadership

• Lead systems engineering activities for software-intensive sustaining projects across compliance, service, cybersecurity, and cost initiatives.
• Own system- and software-level requirements, architecture, interfaces, and traceability for existing products.
• Apply disciplined software systems engineering practices aligned with regulated SDLC frameworks, V-Model execution, and MBSE principles.
• Serve as the technical integrator between software, electrical, mechanical, and system components.

Architecture, Integration & Risk Management

• Define and maintain software-centric system architectures, including software-hardware interfaces and data flows.
• Conduct trade studies, impact analyses, and architectural assessments for software changes in complex systems.
• Lead system-level risk management activities, including software hazard analysis, cybersecurity risk assessment, and root cause investigations.
• Ensure software changes preserve system safety, performance, reliability, and usability.

Verification, Validation & Regulated SDLC

• Define and execute software-focused system verification and validation strategies, including development of test plans, protocols, and reports.
• Ensure software requirements are fully traceable through implementation, verification, and validation.
• Support compliance with Medical Industry regulatory requirements, industry standards, and internal Quality Management System (QMS) processes.
• Maintain audit-ready documentation supporting software lifecycle and system changes.

Cross-Functional & Technical Collaboration

• Partner closely with Software Engineering, Systems, Quality, Manufacturing, Cybersecurity, and Service teams to drive integrated execution.
• Act as a technical authority for software-related system behavior, dependencies, and failure modes.
• Support software release activities, system integration testing, and field issue resolution.

People Leadership & Technical Mentorship

• Mentor and guide software and systems engineers on software-centric systems engineering best practices.
• Contribute to the definition and continuous improvement of software systems engineering processes and standards.
• Influence technical direction across distributed, matrixed R&D organizations.

Qualifications:

• Bachelor’s or Master’s degree in Software Engineering, Computer Engineering, Systems Engineering, or a related technical discipline. (Master’s degree preferred)

Required:

Experience

• 5+ years of experience in systems engineering roles with strong software focus.
• Proven experience working on software-intensive, multidisciplinary systems in regulated environments.
• Demonstrated experience with regulated software development lifecycles, V-Model execution, and systems engineering best practices.
• Experience supporting sustaining engineering, post-market changes, and software lifecycle management.
• Experience in medical devices or other highly regulated industries (e.g., cybersecurity, financial services platforms, aerospace) preferred.

Technical Skills

• Strong understanding of software architecture, system integration, and software-hardware interaction.
• Experience with requirements management, system modeling, and traceability tools.
• Familiarity with engineering and analysis tools (e.g., MATLAB, Minitab, modeling tools); software design and analysis tools a plus.
• Knowledge of cybersecurity, safety-critical software, or regulated embedded systems is highly desirable.

Position Summary:

The Senior Software R&D Systems Engineer provides technical leadership for software-intensive sustaining initiatives across a portfolio of blood and cell therapy capital equipment systems. This role leads the definition, integration, and validation of complex systems with a strong emphasis on software architecture, software-hardware interaction, and system-level behavior in a highly regulated environment following the INCOSE principles and values.

Focused on sustaining and lifecycle management activities, this position ensures that software changes—driven by compliance, serviceability, cybersecurity, reliability, and cost—are safely and effectively integrated into existing platforms. The Senior Software R&D Systems Engineer partners closely with software, hardware, quality, manufacturing, and service teams to ensure continued system performance, reliability, and regulatory compliance.

Key Responsibilities:

Software-Centric Systems Engineering Leadership

• Lead systems engineering activities for software-intensive sustaining projects across compliance, service, cybersecurity, and cost initiatives.
• Own system- and software-level requirements, architecture, interfaces, and traceability for existing products.
• Apply disciplined software systems engineering practices aligned with regulated SDLC frameworks, V-Model execution, and MBSE principles.
• Serve as the technical integrator between software, electrical, mechanical, and system components.

Architecture, Integration & Risk Management

• Define and maintain software-centric system architectures, including software-hardware interfaces and data flows.
• Conduct trade studies, impact analyses, and architectural assessments for software changes in complex systems.
• Lead system-level risk management activities, including software hazard analysis, cybersecurity risk assessment, and root cause investigations.
• Ensure software changes preserve system safety, performance, reliability, and usability.

Verification, Validation & Regulated SDLC

• Define and execute software-focused system verification and validation strategies, including development of test plans, protocols, and reports.
• Ensure software requirements are fully traceable through implementation, verification, and validation.
• Support compliance with Medical Industry regulatory requirements, industry standards, and internal Quality Management System (QMS) processes.
• Maintain audit-ready documentation supporting software lifecycle and system changes.

Cross-Functional & Technical Collaboration

• Partner closely with Software Engineering, Systems, Quality, Manufacturing, Cybersecurity, and Service teams to drive integrated execution.
• Act as a technical authority for software-related system behavior, dependencies, and failure modes.
• Support software release activities, system integration testing, and field issue resolution.

People Leadership & Technical Mentorship

• Mentor and guide software and systems engineers on software-centric systems engineering best practices.
• Contribute to the definition and continuous improvement of software systems engineering processes and standards.
• Influence technical direction across distributed, matrixed R&D organizations.

Qualifications:

• Bachelor’s or Master’s degree in Software Engineering, Computer Engineering, Systems Engineering, or a related technical discipline. (Master’s degree preferred)

Required:

Experience

• 5+ years of experience in systems engineering roles with strong software focus.
• Proven experience working on software-intensive, multidisciplinary systems in regulated environments.
• Demonstrated experience with regulated software development lifecycles, V-Model execution, and systems engineering best practices.
• Experience supporting sustaining engineering, post-market changes, and software lifecycle management.
• Experience in medical devices or other highly regulated industries (e.g., cybersecurity, financial services platforms, aerospace) preferred.

Technical Skills

• Strong understanding of software architecture, system integration, and software-hardware interaction.
• Experience with requirements management, system modeling, and traceability tools.
• Familiarity with engineering and analysis tools (e.g., MATLAB, Minitab, modeling tools); software design and analysis tools a plus.
• Knowledge of cybersecurity, safety-critical software, or regulated embedded systems is highly desirable.