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