Systems Engineers

New Kensington, PA, US • Posted 16 hours ago • Updated 3 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

Electronic Engineering
Computer Science
Systems Architecture
Systems Design
Electromechanics
Computer Hardware
Product Development
Lifecycle Management
Continuous Integration
Continuous Delivery
Systems Analysis
Modeling
Optimization
Research
Research and Development
Manufacturing
System Documentation
Regulatory Compliance
Mentorship
System Requirements
Systems Engineering
Process Improvement
Lean Methodology
Medical Devices
ISO 9000
Risk Management
Electrical Engineering
Mechanical Engineering
Test Plans
V-Model

Summary

Minimum required Skills/Education:

Bachelor's / Master's Degree in Electrical Engineering, Electronic Engineering, Mechanical Engineering, Computer Science Engineering or equivalent.
Minimum 5 years of experience with Bachelor's OR Minimum 3 years of experience with Master's in areas such as System Architecture, System Design, Hardware Engineering or equivalent.
Engineering Professional (CSEP).
Significant experience in New Product Development (NPD) and can speak to experience through the full product life cycle.
Expertise developing electromechanical devices with hardware and software elements.
Deep understanding of medical device standards such as ISO 14971 and the 60601 series.
Product Development Lifecycle Management.
Simulation Software.
CI/CD

Job Responsibilities:

Perform system analyses and modeling to identify optimization opportunities and risks.
Apply research and industry trends to improve system designs.
Coordinate systems engineering requirements across R&D, manufacturing, and regulatory teams.
Review system documentation to ensure compliance with engineering standards and regulations.
Lead development and execution of systems engineering strategies.
Mentor junior systems engineers on methods and best practices.
Analyze system requirements and produce detailed design specifications.
Introduce and test new systems engineering tools and methodologies.
Serve as a technical authority for complex systems engineering issues.
Lead cross-functional process improvement initiatives using lean methods.
Write product and element requirements with rationale.
Decompose medical device standards (IEC 60601-1-11, ISO 80601?2?70, ISO 80601?2?72).
Lead deep-dive FMEAs.
Evaluate requirement failures and translate findings into subsystem requirements.
Ensure control measures flow into the Risk Management File and DHF.
Translate system-level risks into software, electrical, and mechanical requirements.
Develop V&V protocols and test plans.
Build trace matrices across the V-model.
Lead technical reviews to align cross-functional teams.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: d36cf8ec957ba7dbd17096164a5a8745
Posted 16 hours ago

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Systems Engineers

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Job Details

Skills

Summary

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