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Sr Software Systems Engineer R&D (Pinares, CR) @ Terumo BCT, Inc.

Pinares, CROnsiteFull-timePosted 12 days ago

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<p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Position Summary:</span></strong></p> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif"> </span></strong></p> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">The Senior Software R&amp;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.</span></p> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">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&amp;D Systems Engineer partners closely with software, hardware, quality, manufacturing, and service teams to ensure continued system performance, reliability, and regulatory compliance.</span></p> <p style="text-align:justify;margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Key Responsibilities:</span></strong></p> <p style="text-align:justify;margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif"> </span></strong></p> <p style="margin:0.0in 0.0in 0.0in 0.5in;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Software-Centric Systems Engineering Leadership</span></strong></p> <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Lead systems engineering activities for software-intensive sustaining projects across compliance, service, cybersecurity, and cost initiatives.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Own system- and software-level requirements, architecture, interfaces, and traceability for existing products.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Apply disciplined software systems engineering practices aligned with regulated SDLC frameworks, V-Model execution, and MBSE principles.</span></li> <li style="margin:0.0in 0.0in 8.0pt 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Serve as the technical integrator between software, electrical, mechanical, and system components.</span></li> </ul> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0in 0.0in 0.0in 0.5in;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Architecture, Integration &amp; Risk Management</span></strong></p> <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Define and maintain software-centric system architectures, including software-hardware interfaces and data flows.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Conduct trade studies, impact analyses, and architectural assessments for software changes in complex systems.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Lead system-level risk management activities, including software hazard analysis, cybersecurity risk assessment, and root cause investigations.</span></li> <li style="margin:0.0in 0.0in 8.0pt 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Ensure software changes preserve system safety, performance, reliability, and usability.</span></li> </ul> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0in 0.0in 0.0in 0.5in;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Verification, Validation &amp; Regulated SDLC</span></strong></p> <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Define and execute software-focused system verification and validation strategies, including development of test plans, protocols, and reports.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Ensure software requirements are fully traceable through implementation, verification, and validation.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Support compliance with Medical Industry regulatory requirements, industry standards, and internal Quality Management System (QMS) processes.</span></li> <li style="margin:0.0in 0.0in 8.0pt 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Maintain audit-ready documentation supporting software lifecycle and system changes.</span></li> </ul> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0in 0.0in 0.0in 0.5in;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Cross-Functional &amp; Technical Collaboration</span></strong></p> <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Partner closely with Software Engineering, Systems, Quality, Manufacturing, Cybersecurity, and Service teams to drive integrated execution.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Act as a technical authority for software-related system behavior, dependencies, and failure modes.</span></li> <li style="margin:0.0in 0.0in 8.0pt 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Support software release activities, system integration testing, and field issue resolution.</span></li> </ul> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0in 0.0in 0.0in 0.5in;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">People Leadership &amp; Technical Mentorship</span></strong></p> <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Mentor and guide software and systems engineers on software-centric systems engineering best practices.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Contribute to the definition and continuous improvement of software systems engineering processes and standards.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Influence technical direction across distributed, matrixed R&amp;D organizations.</span></li> </ul> <p style="line-height:normal;margin:0.0in 0.0in 8.0pt 0.5in;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Qualifications:</span></strong></p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Bachelor’s or Master’s degree in Software Engineering, Computer Engineering, Systems Engineering, or a related technical discipline. (Master’s degree preferred)</span></li> </ul> <p style="text-align:justify;margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif"> </span></strong></p> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Required:</span></strong></p> <p style="line-height:115%;margin:0.0in 0.0in 8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="line-height:115%;margin:0.0in 0.0in 8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Experience</span></strong></p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">5+ years of experience in systems engineering roles with strong software focus.</span></li> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Proven experience working on software-intensive, multidisciplinary systems in regulated environments.</span></li> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Demonstrated experience with regulated software development lifecycles, V-Model execution, and systems engineering best practices.</span></li> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Experience supporting sustaining engineering, post-market changes, and software lifecycle management.</span></li> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Experience in medical devices or other highly regulated industries (e.g., cybersecurity, financial services platforms, aerospace) preferred.</span></li> </ul> <p style="line-height:115%;margin:0.0in 0.0in 8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="line-height:115%;margin:0.0in 0.0in 8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Technical Skills</span></strong></p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Strong understanding of software architecture, system integration, and software-hardware interaction.</span></li> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Experience with requirements management, system modeling, and traceability tools.</span></li> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Familiarity with engineering and analysis tools (e.g., MATLAB, Minitab, modeling tools); software design and analysis tools a plus.</span></li> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Knowledge of cybersecurity, safety-critical software, or regulated embedded systems is highly desirable.</span></li> </ul><p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Position Summary:</span></strong></p> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif"> </span></strong></p> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">The Senior Software R&amp;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.</span></p> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">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&amp;D Systems Engineer partners closely with software, hardware, quality, manufacturing, and service teams to ensure continued system performance, reliability, and regulatory compliance.</span></p> <p style="text-align:justify;margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Key Responsibilities:</span></strong></p> <p style="text-align:justify;margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif"> </span></strong></p> <p style="margin:0.0in 0.0in 0.0in 0.5in;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Software-Centric Systems Engineering Leadership</span></strong></p> <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Lead systems engineering activities for software-intensive sustaining projects across compliance, service, cybersecurity, and cost initiatives.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Own system- and software-level requirements, architecture, interfaces, and traceability for existing products.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Apply disciplined software systems engineering practices aligned with regulated SDLC frameworks, V-Model execution, and MBSE principles.</span></li> <li style="margin:0.0in 0.0in 8.0pt 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Serve as the technical integrator between software, electrical, mechanical, and system components.</span></li> </ul> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0in 0.0in 0.0in 0.5in;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Architecture, Integration &amp; Risk Management</span></strong></p> <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Define and maintain software-centric system architectures, including software-hardware interfaces and data flows.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Conduct trade studies, impact analyses, and architectural assessments for software changes in complex systems.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Lead system-level risk management activities, including software hazard analysis, cybersecurity risk assessment, and root cause investigations.</span></li> <li style="margin:0.0in 0.0in 8.0pt 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Ensure software changes preserve system safety, performance, reliability, and usability.</span></li> </ul> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0in 0.0in 0.0in 0.5in;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Verification, Validation &amp; Regulated SDLC</span></strong></p> <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Define and execute software-focused system verification and validation strategies, including development of test plans, protocols, and reports.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Ensure software requirements are fully traceable through implementation, verification, and validation.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Support compliance with Medical Industry regulatory requirements, industry standards, and internal Quality Management System (QMS) processes.</span></li> <li style="margin:0.0in 0.0in 8.0pt 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Maintain audit-ready documentation supporting software lifecycle and system changes.</span></li> </ul> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0in 0.0in 0.0in 0.5in;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Cross-Functional &amp; Technical Collaboration</span></strong></p> <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Partner closely with Software Engineering, Systems, Quality, Manufacturing, Cybersecurity, and Service teams to drive integrated execution.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Act as a technical authority for software-related system behavior, dependencies, and failure modes.</span></li> <li style="margin:0.0in 0.0in 8.0pt 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Support software release activities, system integration testing, and field issue resolution.</span></li> </ul> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0in 0.0in 0.0in 0.5in;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">People Leadership &amp; Technical Mentorship</span></strong></p> <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Mentor and guide software and systems engineers on software-centric systems engineering best practices.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Contribute to the definition and continuous improvement of software systems engineering processes and standards.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Influence technical direction across distributed, matrixed R&amp;D organizations.</span></li> </ul> <p style="line-height:normal;margin:0.0in 0.0in 8.0pt 0.5in;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Qualifications:</span></strong></p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Bachelor’s or Master’s degree in Software Engineering, Computer Engineering, Systems Engineering, or a related technical discipline. (Master’s degree preferred)</span></li> </ul> <p style="text-align:justify;margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif"> </span></strong></p> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Required:</span></strong></p> <p style="line-height:115%;margin:0.0in 0.0in 8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="line-height:115%;margin:0.0in 0.0in 8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Experience</span></strong></p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">5+ years of experience in systems engineering roles with strong software focus.</span></li> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Proven experience working on software-intensive, multidisciplinary systems in regulated environments.</span></li> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Demonstrated experience with regulated software development lifecycles, V-Model execution, and systems engineering best practices.</span></li> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Experience supporting sustaining engineering, post-market changes, and software lifecycle management.</span></li> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Experience in medical devices or other highly regulated industries (e.g., cybersecurity, financial services platforms, aerospace) preferred.</span></li> </ul> <p style="line-height:115%;margin:0.0in 0.0in 8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="line-height:115%;margin:0.0in 0.0in 8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Technical Skills</span></strong></p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Strong understanding of software architecture, system integration, and software-hardware interaction.</span></li> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Experience with requirements management, system modeling, and traceability tools.</span></li> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Familiarity with engineering and analysis tools (e.g., MATLAB, Minitab, modeling tools); software design and analysis tools a plus.</span></li> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Knowledge of cybersecurity, safety-critical software, or regulated embedded systems is highly desirable.</span></li> </ul><p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Position Summary:</span></strong></p> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif"> </span></strong></p> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">The Senior Software R&amp;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.</span></p> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">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&amp;D Systems Engineer partners closely with software, hardware, quality, manufacturing, and service teams to ensure continued system performance, reliability, and regulatory compliance.</span></p> <p style="text-align:justify;margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Key Responsibilities:</span></strong></p> <p style="text-align:justify;margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif"> </span></strong></p> <p style="margin:0.0in 0.0in 0.0in 0.5in;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Software-Centric Systems Engineering Leadership</span></strong></p> <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Lead systems engineering activities for software-intensive sustaining projects across compliance, service, cybersecurity, and cost initiatives.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Own system- and software-level requirements, architecture, interfaces, and traceability for existing products.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Apply disciplined software systems engineering practices aligned with regulated SDLC frameworks, V-Model execution, and MBSE principles.</span></li> <li style="margin:0.0in 0.0in 8.0pt 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Serve as the technical integrator between software, electrical, mechanical, and system components.</span></li> </ul> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0in 0.0in 0.0in 0.5in;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Architecture, Integration &amp; Risk Management</span></strong></p> <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Define and maintain software-centric system architectures, including software-hardware interfaces and data flows.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Conduct trade studies, impact analyses, and architectural assessments for software changes in complex systems.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Lead system-level risk management activities, including software hazard analysis, cybersecurity risk assessment, and root cause investigations.</span></li> <li style="margin:0.0in 0.0in 8.0pt 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Ensure software changes preserve system safety, performance, reliability, and usability.</span></li> </ul> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0in 0.0in 0.0in 0.5in;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Verification, Validation &amp; Regulated SDLC</span></strong></p> <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Define and execute software-focused system verification and validation strategies, including development of test plans, protocols, and reports.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Ensure software requirements are fully traceable through implementation, verification, and validation.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Support compliance with Medical Industry regulatory requirements, industry standards, and internal Quality Management System (QMS) processes.</span></li> <li style="margin:0.0in 0.0in 8.0pt 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Maintain audit-ready documentation supporting software lifecycle and system changes.</span></li> </ul> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0in 0.0in 0.0in 0.5in;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Cross-Functional &amp; Technical Collaboration</span></strong></p> <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Partner closely with Software Engineering, Systems, Quality, Manufacturing, Cybersecurity, and Service teams to drive integrated execution.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Act as a technical authority for software-related system behavior, dependencies, and failure modes.</span></li> <li style="margin:0.0in 0.0in 8.0pt 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Support software release activities, system integration testing, and field issue resolution.</span></li> </ul> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0in 0.0in 0.0in 0.5in;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">People Leadership &amp; Technical Mentorship</span></strong></p> <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Mentor and guide software and systems engineers on software-centric systems engineering best practices.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Contribute to the definition and continuous improvement of software systems engineering processes and standards.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Influence technical direction across distributed, matrixed R&amp;D organizations.</span></li> </ul> <p style="line-height:normal;margin:0.0in 0.0in 8.0pt 0.5in;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Qualifications:</span></strong></p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Bachelor’s or Master’s degree in Software Engineering, Computer Engineering, Systems Engineering, or a related technical discipline. (Master’s degree preferred)</span></li> </ul> <p style="text-align:justify;margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif"> </span></strong></p> <p style="margin:0.0in 0.0in 8.0pt;line-height:106%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Required:</span></strong></p> <p style="line-height:115%;margin:0.0in 0.0in 8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="line-height:115%;margin:0.0in 0.0in 8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Experience</span></strong></p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">5+ years of experience in systems engineering roles with strong software focus.</span></li> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Proven experience working on software-intensive, multidisciplinary systems in regulated environments.</span></li> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Demonstrated experience with regulated software development lifecycles, V-Model execution, and systems engineering best practices.</span></li> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Experience supporting sustaining engineering, post-market changes, and software lifecycle management.</span></li> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Experience in medical devices or other highly regulated industries (e.g., cybersecurity, financial services platforms, aerospace) preferred.</span></li> </ul> <p style="line-height:115%;margin:0.0in 0.0in 8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="line-height:115%;margin:0.0in 0.0in 8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-family:Arial, sans-serif">Technical Skills</span></strong></p> <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Strong understanding of software architecture, system integration, and software-hardware interaction.</span></li> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Experience with requirements management, system modeling, and traceability tools.</span></li> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Familiarity with engineering and analysis tools (e.g., MATLAB, Minitab, modeling tools); software design and analysis tools a plus.</span></li> <li style="line-height:115%;margin-top:0.0in;margin-right:0.0in;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:Arial, sans-serif">Knowledge of cybersecurity, safety-critical software, or regulated embedded systems is highly desirable.</span></li> </ul>

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Sr Software Systems Engineer R&D (Pinares, CR) at Terumo BCT, Inc. | ResuMinder Jobs