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Amazon S3
Computer Hardware
Electrical Engineering
ISO 9000
FMEA
Medical Devices
Continuous Delivery
Manufacturing
Mentorship
Product Development
Regulatory Compliance

Summary

System Engineer (Hybrid)

Location: New Kensington, PA (Local candidates preferred)
Work Schedule: Hybrid – 3 days/week onsite

Bachelor''s: 5+ years of relevant experience OR

Master''s: 3+ years of relevant experience

Job Summary

Philips is seeking an experienced System Engineer with a strong background in medical device development, systems engineering, and New Product Development (NPD). The ideal candidate will have expertise in system architecture, risk management, requirements engineering, and medical device regulatory standards while working across the full product lifecycle.

Key Responsibilities

Lead system architecture, system analysis, and performance assessments using advanced modeling and simulation techniques.
Develop product and element requirements with clear technical rationale.
Interpret and decompose medical device standards including:

IEC 60601-1-11
ISO 80601-2-70
ISO 80601-2-72

Perform and lead Failure Mode & Effects Analysis (FMEA) to identify risks and translate findings into subsystem requirements.
Ensure all risk control measures are documented in the Risk Management File (RMF) and Design History File (DHF) with submission-ready audit trails.
Define system-level requirements that drive software, electrical, and mechanical subsystem design.
Develop verification & validation (V&V) protocols, test plans, and traceability matrices across the V-model.
Conduct technical design reviews and collaborate with cross-functional teams including R&D, Manufacturing, Quality, and Regulatory Affairs.
Review system documentation to ensure compliance with systems engineering principles and medical device regulations.
Drive process improvements and mentor junior systems engineers.

Required Qualifications

Bachelor''s or Master''s degree in:

Electrical Engineering
Electronics Engineering
Mechanical Engineering
Computer Science
Or related engineering discipline

Strong experience in:

System Architecture
System Design
Hardware Engineering
Medical Device Product Development

Proven experience throughout the full New Product Development (NPD) lifecycle.
Expertise in developing electromechanical products with both hardware and software components.
Strong knowledge of:

ISO 14971
IEC 60601 Series
Medical device regulatory standards

Experience with requirements management, risk management, and systems integration.

Preferred Qualifications

Certified Systems Engineering Professional (CSEP) certification.
Experience with CI/CD practices.
Strong background in quality systems and regulatory compliance.

Preferred Skills

Systems Engineering
Systems Architecture & Design
Requirements Analysis & Management
Product Development Lifecycle (NPD)
Risk Management
FMEA
V&V Planning
Traceability Matrix (V-Model)
Medical Device Standards
Systems Integration
Research & Analysis
Continuous Improvement
Strategic Planning
Simulation Tools
CI/CD

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: 10238807
Position Id: 9026659
Posted 16 hours ago

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Manish Singh Singh

Recruiter @ Sriven Systems Inc.

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