Systems Engineer III

Engineer IIIThe Engineer III will be an individual contributor to support systems engineering programs related to software within a regulated medical device environment. This person will serve as a hands-on technical aid across software related system investigations, root cause analysis, risk assessments, design changes, and product support activities. This is not a people management role. The right candidate will execute technical workstreams and programs tied to software driven systems, working closely with software, hardware, systems, quality, manufacturing, and regulatory teams to troubleshoot complex issues and drive deliverables to closure.The annual base salary range for this role is currently $90,000 to $120,000. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave.Key AccountabilitiesEssential Functions:Execute software and systems engineering workstreams tied to investigations, root cause analysis, risk assessments, design changes, and product support activitiesTroubleshoot software driven system issues across software, hardware, firmware, electrical components, boards, interfaces, configurations, workflows, and integrated product platformsSupport investigations for product defects, field issues, manufacturing issues, complaints, CAPAs, system failures, and performance concernsAssess the technical impact of component swaps, board swaps, software changes, firmware updates, configuration changes, and system modificationsReview technical data, logs, test results, trends, and investigation outputs to help determine root cause, risk, and next stepsDocument investigation findings, technical rationale, impact assessments, risk evaluations, and recommended corrective actionsSupport design control activities, including technical documentation, specifications, test plans, protocols, reports, traceability, and risk documentationPartner cross functionally with systems, software, hardware, electrical, quality, manufacturing, regulatory, and operations teams to resolve technical issuesLead or support development of test methods, troubleshooting approaches, technical processes, specifications, and system level verification activitiesCoordinate technical inputs across functions to keep programs, investigations, and deliverables movingCommunicate technical issues clearly through documentation, presentations, technical summaries, and team discussionsRecommend and support process improvements related to investigations, root cause analysis, software/system troubleshooting, risk management, and design control practicesSkills & Capabilities:Experience serving as a technical lead, program technical lead, senior individual contributor, or key technical resource on software/system engineering effortsExperience leading technical workstreams or cross functional engineering deliverables without direct people management responsibilityExperience working in a regulated medical device, in vitro diagnostics, life sciences, or similarly regulated environmentStrong background in software driven systems, system level troubleshooting, root cause analysis, and technical investigationsAbility to evaluate issues across software, hardware, firmware, electrical, board, component, and system level interfacesExperience with risk management, impact assessments, product changes, design changes, and design control documentationExperience supporting technical assessments involving component swaps, board swaps, system updates, software changes, and product performance issuesExperience/familiarity supporting CAPA, complaints, product defects, or post market investigationsStrong cross functional communication skills with the ability to explain technical issues clearly to technical and non technical stakeholdersQualificationsMinimum Knowledge & Experience Required for the Position:Bachelor's degree in Engineering, Science or a related field5 years of relevant experience in software engineering, systems engineering, product development, sustaining engineering, or a similar technical role1-3 years of product development or relevant experience for advanced degreesFor internal candidate promotion: Demonstrated proficiency in meeting all competencies of current level and acceptable performance history may be used in lieu of experienceIn vitro medical device experience highly desired.Additional Skills/Knowledge:Language: Proficiency in English language requiredInternational Mobility:Required: NoTravel Requirements:Some domestic and international travel may be required.