Systems Engineer III

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., * 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

• 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, Minimum Knowledge & Experience Required for the Position:
• 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
• For internal candidate promotion: 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.

Additional Skills/Knowledge:

• Language: Proficiency in English language required

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.

Werfen

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care., We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team., At present, Werfen operates directly in over 30 countries and in more than 100 territories through distributors