Systems Engineering Analysis, Senior

Our client is seeking an experienced Systems Engineer to support Software verification within a regulated medical device environment. This person will serve as a hands‑on technical lead across software related system investigations, root cause analysis, risk assessments, design changes, and product support activities. The right candidate will lead 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.

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.

Lead 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

Recommends and leads implementation of improvement initiatives to aid department practices.

Internal Networking/Key Relationships:

Statistical Analysis (if required by the function), Root Cause Analysis, Creative Problem Solving, Critical Thinking

Bachelor's degree in Engineering, Science or a related field

Demonstrated proficiency in meeting all competencies of current level and acceptable performance history may be used in lieu of experience

In vitro medical device experience highly desired.

Language: Proficiency in English language required

International Mobility:

Travel Requirements:

Some domestic and international travel may be required.

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