Systems Engineer III

Werfen•Bedford, MA

About The Position

The 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.

Requirements

Bachelor's degree in Engineering, Science or a related field
5 years of relevant experience in software engineering, systems engineering, product development, sustaining engineering, or a similar technical role
1-3 years of product development or relevant experience for advanced degrees
Proficiency in English language required

Nice To Haves

Experience serving as a technical lead, program technical lead, senior individual contributor, or key technical resource on software/system engineering efforts
Experience leading technical workstreams or cross functional engineering deliverables without direct people management responsibility
Experience working in a regulated medical device, in vitro diagnostics, life sciences, or similarly regulated environment
Strong background in software driven systems, system level troubleshooting, root cause analysis, and technical investigations
Ability to evaluate issues across software, hardware, firmware, electrical, board, component, and system level interfaces
Experience with risk management, impact assessments, product changes, design changes, and design control documentation
Experience supporting technical assessments involving component swaps, board swaps, system updates, software changes, and product performance issues
Experience/familiarity supporting CAPA, complaints, product defects, or post market investigations
Strong cross functional communication skills with the ability to explain technical issues clearly to technical and non technical stakeholders
In vitro medical device experience highly desired.

Responsibilities

Execute software and systems engineering workstreams tied to investigations, root cause analysis, risk assessments, design changes, and product support activities
Troubleshoot software driven system issues across software, hardware, firmware, electrical components, boards, interfaces, configurations, workflows, and integrated product platforms
Support investigations for product defects, field issues, manufacturing issues, complaints, CAPAs, system failures, and performance concerns
Assess the technical impact of component swaps, board swaps, software changes, firmware updates, configuration changes, and system modifications
Review technical data, logs, test results, trends, and investigation outputs to help determine root cause, risk, and next steps
Document investigation findings, technical rationale, impact assessments, risk evaluations, and recommended corrective actions
Support design control activities, including technical documentation, specifications, test plans, protocols, reports, traceability, and risk documentation
Partner cross functionally with systems, software, hardware, electrical, quality, manufacturing, regulatory, and operations teams to resolve technical issues
Lead or support development of test methods, troubleshooting approaches, technical processes, specifications, and system level verification activities
Coordinate technical inputs across functions to keep programs, investigations, and deliverables moving
Communicate technical issues clearly through documentation, presentations, technical summaries, and team discussions
Recommend and support process improvements related to investigations, root cause analysis, software/system troubleshooting, risk management, and design control practices