OverviewPosition Summary: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. This is not a people management role. 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.
The annual base salary range for this role is currently $130,000 to $160,000. 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.
ResponsibilitiesKey Accountabilities:Essential Functions:- 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
- 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
Secondary Functions:- May review and provide input to deliverables from other functions.
- Recommends and leads implementation of improvement initiatives to aid department practices.
- May be assigned CAPA ownership.
Internal Networking/Key Relationships:To be determined based on department needs, to include interactions such as:
- Will interface on a regular basis with groups across the organization as needed
Skills & Capabilities:The ideal candidate for this position will exhibit the following skills and capabilities:
- Statistical Analysis (if required by the function), Root Cause Analysis, Creative Problem Solving, Critical Thinking
- Technically adept and confident
- Leadership: Accountability, Decision Making, Influence, Communication
- Mentoring
QualificationsMinimum Knowledge & Experience Required for the Position:Education:- Bachelor's degree in Engineering, Science or a related field
Experience: - Ten years of product development or relevant experience
- Six to eight 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
International Mobility:Travel Requirements:- Some domestic and international travel may be required.
